FDA.reportPublic FDA data

CVS PHARMACY

Product NDC
51316-154
11-digit product format
513160154
Labeler code
51316
Product ID
51316-154_8843bb98-915c-4d9c-ae1a-750c65938360
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CVS PHARMACY, INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-03
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
CVS PHARMACY
Brand name suffix
Childrens Allergy Chews
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049900Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
569b8efa-8458-49f7-a665-6b7016a10505Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-154-18CVS PHARMACYChildrens Allergy Chews3 in 1 CARTONTABLET, CHEWABLE32
51316-154-18CVS PHARMACYChildrens Allergy Chews6 in 1 BLISTER PACKTABLET, CHEWABLE62
51316-154-36CVS PHARMACYChildrens Allergy Chews12 in 1 BLISTER PACKTABLET, CHEWABLE122
51316-154-36CVS PHARMACYChildrens Allergy Chews3 in 1 CARTONTABLET, CHEWABLE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-154CVS PHARMACY CHILDRENS ALLERGY CHEWS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [CVS PHARMACY, INC.]1Current NDC, 4 package rows20250321_569b8efa-8458-49f7-a665-6b7016a10505.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 127 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILJell Pharmaceuticals Pvt Ltd.d80cad8d-da4c-049d-e053-2a95a90ac20e2024-12-18WarningsExact identifier
application number: M012
Afrin OriginalOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc.8a97c012-6a47-4607-9389-58a4eed17b082024-12-18WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILOrazen Incecddaa3b-e18f-1c74-e053-2995a90ad86a2024-12-18WarningsExact identifier
application number: M012
Rite Aid Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLRite Aiddfedbef1-8062-432d-e053-2a95a90a09e92024-12-18WarningsExact identifier
application number: M012
TheraCare Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILVeridian Healthcaref7801843-f96c-710e-e053-6294a90a50862024-12-18WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief G450GUAIFENESINRugby Laboratoriesa6aa8cbd-21ff-4f84-b338-c05c2d46e6df2024-12-18WarningsExact identifier
application number: M012
Refenesen Mucus ReliefGUAIFENESINReese Pharmaceutical Co861dffb7-8bf4-4f03-bcc2-ed8a35bc341d2024-12-18WarningsExact identifier
application number: M012
Marcs Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINMarc Glassman Incbe3ad54f-522c-440d-b8c7-9664f60155662024-12-18WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCda6bd9df-aebe-4fe5-b20b-01bda3b9e7ee2024-12-18WarningsExact identifier
application number: M012
Family Wellness Chest Congestion ReliefGUAIFENESINFamily Dollar Services Inc412f3459-4c22-4822-86bd-011fc3e91ca62024-12-18WarningsExact identifier
application number: M012
Marcs Mucus ReliefGUAIFENESINMarc Glassman Inc455b9f01-206c-4534-a006-292d2bd48f472024-12-18WarningsExact identifier
application number: M012
Leader Chest Congestion Relief G450GUAIFENESINCardinal Health4586a83f-077c-4fb3-adfe-7a9497a78d972024-12-18WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC5372f764-985e-4a42-bc97-cb0dc90fcd9c2024-12-18WarningsExact identifier
application number: M012
TopCare Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTOPCO ASSOCIATES LLC5a2d0464-038d-4c3f-b39e-ee9984fb383e2024-12-18WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINValu Mercha72b6a97-f97f-44bb-8d55-ac48b8ba45c52024-12-18WarningsExact identifier
application number: M012
Harris Teeter Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter4ebe1d94-bb15-4250-a4c2-8cd45743c7dd2024-12-18WarningsExact identifier
application number: M012
Care One Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRETAIL BUSINESS SERVICES , LLCf6657dee-9f32-45b1-8e44-1ad67a4a68bd2024-12-18WarningsExact identifier
application number: M012
Childrens Metapp DaytimeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLGuardian Drug Company40565500-944b-47f2-8563-5df05469e4182024-12-18WarningsExact identifier
application number: M012
CVS Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCVS Pharmacy, Inc.884abed2-e355-4134-92f1-591f3a18f71d2024-12-18WarningsExact identifier
application number: M012
CVS Health Chest Congestion Relief PEGUAIFENESIN/PHENYLEPHRINECVS Pharmacy, Inc.a49020e8-739e-47ec-8141-e866479a3ab32024-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN569b8efa-8458-49f7-a665-6b7016a105052
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD569b8efa-8458-49f7-a665-6b7016a105052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-154-18513160154183 BLISTER PACK in 1 CARTON (51316-154-18) / 6 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2025-03-03NoNoCurrent
51316-154-36513160154363 BLISTER PACK in 1 CARTON (51316-154-36) / 12 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2025-03-03NoNoCurrent