NDC 51316-604 - Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51316-604
Package NDCs from labels
51316-604-05
Manufacturer
CVS Pharmacy, Inc
Effective date
2025-10-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen, Dextromethorphan HBr - CVS Pharmacy, IncCVS Pharmacy, Inc2025-10-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-604-05Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate6 in 1 PACKETPOWDER6 in 1230 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-604ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE KIT [CVS PHARMACY, INC]1Unmatched20240410_1532ee21-e114-ded7-e063-6294a90ab025.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 207 of 333 · 6,646 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAYTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEKroger Companybc00bbf8-52bb-fa75-e053-2a95a90a94062025-02-11WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
CALCAREA PHOSPHORICA 6XCALCAREA PHOSPHORICASEVENE USAff0ed204-c5c2-b7f9-e053-6294a90ab1892025-02-11WarningsExact identifier
unii: 91D9GV0Z28
SILICEA 6XSILICEASEVENE USAff0e0009-8bbe-e0eb-e053-6294a90afa822025-02-11WarningsExact identifier
unii: ETJ7Z6XBU4
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINELEADER/ Cardinal Health 110, Inc.b3773f02-02a9-33c8-e053-2995a90a22352025-02-11WarningsExact identifier
unii: 362O9ITL9D
Daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELSTIME CAP LABORATORIES, INC.fd24653e-c4fa-3c09-e053-6394a90aaa9e2025-02-10WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELSTIME CAP LABORATORIES INC.fd81dd4b-9617-f4c1-e053-6394a90a5e722025-02-10WarningsExact identifier
application number: M012
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC.c9f80d24-bd05-e1ce-e053-2995a90aa6462025-02-10WarningsExact identifier
unii: 362O9ITL9D
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRPUBLIX SUPER MARKETS, INC74fa022a-bad9-4d0f-8dda-5624fae3867b2025-02-10WarningsExact identifier
unii: 9D2RTI9KYH
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDOLGENCORP, LLCbe2207b7-b8f8-7fba-e053-2a95a90abd162025-02-10WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEKroger Companybc0115a3-5322-855d-e053-2995a90aba272025-02-10WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
SILICEA 200ckSILICEASEVENE USAcf89bb22-9e2f-9143-e053-2995a90aff192025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d27b1e4-a966-5495-e053-2a95a90a965b2025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d363a40-a17b-2b6f-e053-2a95a90a33842025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.99fdc906-3a55-e4c4-e053-2a95a90a76ba2025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Day time high blood pressure cold and fluACETAMINOPHEN DEXTROMETHORPHAN HBRCamber Consumer Care09fbd872-0970-4864-9308-4a7b859839202025-02-10WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Cough DropsMENTHOLThe Kroger COf05e11ce-c908-acbc-e053-2a95a90a584e2025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf035c499-cda6-fadf-e053-2995a90af4572025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6d977ce-bbca-f1cc-e053-6394a90acc962025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6da36d3-496d-2336-e053-6394a90a0f832025-02-09WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.