FDA.reportPublic FDA data

Allergy Relief Caplet

Product NDC
36800-937
11-digit product format
368000937
Labeler code
36800
Product ID
36800-937_452adf86-1162-449c-a974-469bfaa20da9
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Allergy Relief Caplet
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
126c05e7-2cd9-47d3-96c3-82305714e1dbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-937-01Allergy Relief Caplet1 in 1 CARTONTABLET, FILM COATED15
36800-937-01Allergy Relief Caplet100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
36800-937-40Allergy Relief Caplet400 in 1 BOTTLETABLET, FILM COATED4005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-937ALLERGY RELIEF CAPLET (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 3 package rows20250112_126c05e7-2cd9-47d3-96c3-82305714e1db.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
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN126c05e7-2cd9-47d3-96c3-82305714e1db5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD126c05e7-2cd9-47d3-96c3-82305714e1db5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-937-01368000937011 BOTTLE, PLASTIC in 1 CARTON (36800-937-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-11-09NoNoCurrent
36800-937-4036800093740400 TABLET, FILM COATED in 1 BOTTLE (36800-937-40) 2021-05-010000-00-00NoNoCurrent