MedPath

Gentle Laxative

Equate 44-607-Gentle

Approved
Approval ID

1c27244f-f0e9-43bf-a5fa-f594952914ca

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Wal-Mart Stores Inc

DUNS: 051957769

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bisacodyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49035-706
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bisacodyl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (33)

BISACODYLActive
Quantity: 5 mg in 1 1
Code: 10X0709Y6I
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Polyvinyl Acetate PhthalateInactive
Code: 58QVG85GW3
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

Principal display panel

equate**™**

NDC 49035-706-12

Compare
to Dulcolax
Pink® active
ingredient*

Gentle
** Laxative**
Bisacodyl USP, 5 mg
Stimulant Laxative

• Gentle, dependable constipation relief

Actual Size

5
** mg**
** EACH**

100
** TABLETS**

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
** SEAL UNDER CAP IS BROKEN OR MISSING**

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
** PRODUCT OF INDIA**

*This product is not manufactured or distributed by
A. Nattermann & Cie. GmbH, owner of the registered trademark
Dulcolax Pink®. 50844 REV0823B60712

Equate 44-607

Equate 44-607

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

Uses

  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Purpose

Stimulant laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

Do not use

if you cannot swallow without chewing.

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting

  • a sudden change in bowel habits that lasts more than 2 weeks

When using this product

  • do not use within 1 hour after taking an antacid or milk
  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness, and cramps

Stop use and ask a doctor if

  • you need to use a laxative for more than 1 week

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

Directions

*do not take more than directed

  • take with a glass of water

adults and children
12 years and over

take 1 to 3 tablets
in a single daily dose

children 6 to under
12 years

take 1 tablet in a
single daily dose

children under 6 years

ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/15/2025

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • avoid excessive humidity

  • use by expiration date on package

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/15/2025

Questions or comments?

1-888-287-1915

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Gentle Laxative - FDA Drug Approval Details