Severe Cold
Equaline 44-503A-CMS Delisted
Approved
Approval ID
cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
United Natural Foods, Inc. dba UNFI
DUNS: 943556183
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code41163-053
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (19)
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT