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FDA Approval

Dulcolax Chewy Fruit Bites Cherry Berry

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Chattem, Inc.
DUNS: 003336013
Effective Date
March 31, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Magnesium hydroxide(600 mg in 1 1)

Products1

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

Dulcolax Chewy Fruit Bites Cherry Berry

Product Details

NDC Product Code
41167-0257
Application Number
505G(a)(3)
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
March 31, 2025
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
Code: NBZ3QY004SClass: ACTIBQuantity: 600 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
CARMINIC ACIDInactive
Code: CID8Z8N95NClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
CORN SYRUPInactive
Code: 9G5L16BK6NClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
FD&C YELLOW NO. 5 ALUMINUM LAKEInactive
Code: JQ6BLH9FR7Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYDROGENATED COCONUT OILInactive
Code: JY81OXM1OMClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NNClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
WHITE WAXInactive
Code: 7G1J5DA97FClass: IACT
ETHYL ACETATEInactive
Code: 76845O8NMZClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
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