MedPath

Dulcolax Chewy Fruit Bites Cherry Berry

Dulcolax Chewy Fruit Bites- Cherry Berry

Approved
Approval ID

b29d2771-f685-45c5-b18b-3ca976df6984

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Mar 31, 2025

Manufacturers
FDA

Chattem, Inc.

DUNS: 003336013

Products 1

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

Magnesium Hydroxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41167-0257
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Magnesium Hydroxide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2025
FDA Product Classification

INGREDIENTS (30)

FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MAGNESIUM HYDROXIDEActive
Quantity: 600 mg in 1 1
Code: NBZ3QY004S
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CARMINIC ACIDInactive
Code: CID8Z8N95N
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C YELLOW NO. 5 ALUMINUM LAKEInactive
Code: JQ6BLH9FR7
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROGENATED COCONUT OILInactive
Code: JY81OXM1OM
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.