FDA.reportPublic FDA data

Allergy Relief

Product NDC
63868-087
11-digit product format
638680087
Labeler code
63868
Product ID
63868-087_24357076-8e9f-69bc-e063-6394a90af9c8
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-11-10
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
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
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8eab9d79-69c1-44b8-9145-a7ebd887d54dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-087-01Allergy Relief1 in 1 CARTONCAPSULE13
63868-087-01Allergy Relief100 in 1 BOTTLE, PLASTICCAPSULE1003
63868-087-24Allergy Relief2 in 1 CARTONCAPSULE23
63868-087-24Allergy Relief12 in 1 BLISTER PACKCAPSULE123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-087-01EA - Each63868-087210f3930-c05e-4412-b846-a3295d8e6cca12014-11-05
63868-087-24EA - Each63868-0878c6d0eff-aac3-46d1-9b21-30275779606412014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
GELATININACTIVE INGREDIENT2G86QN327LALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-087ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]3Current NDC, Legacy NDC, 4 package rows20241013_8eab9d79-69c1-44b8-9145-a7ebd887d54d.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 87 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
up and up Daytime Nighttime Childrens Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationb8a4da0b-e4d3-48e6-b699-cb56c7b67ed72025-11-20WarningsExact identifier
application number: M012
Supress DX Pediatric DropsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISddb95436-7806-4086-af4d-18a6625b5c832025-11-20WarningsExact identifier
application number: M012
Cough Drops Gems Flawless Cherry Flavor 30ctMENTHOLRiclan S.A.0f0260df-89ac-4b83-afea-3aff56ff1b432025-11-18WarningsExact identifier
application number: M012
Cough Drops Gems Flawless Honey Lemon Flavor 30ctMENTHOLRiclan S.A.16f6d531-9298-4172-8d08-ecd87d6add762025-11-18WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCa6f750c8-8738-4965-a3ad-612c246110562025-11-18WarningsExact identifier
application number: M012
YINCHIAOACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.09ba45f6-03e1-46b9-83ab-a618b26267162025-11-18WarningsExact identifier
application number: M012
GANMAOLINGACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.c757a03e-59ea-469c-970d-4bc62e73f36f2025-11-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepacke1d545dc-9222-4d61-964d-1c781215d7d22025-11-18WarningsExact identifier
application number: M012
Goodnow cold flu day relief cold flu night reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGobrands, Inc7590d0c6-121e-4016-b6bb-534c5d0a79702025-11-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDER J General Corporationd786ae07-ce57-44c7-9ba5-f4c87df115de2025-11-17WarningsExact identifier
application number: M012
Benadryl AllergyDIPHENHYDRAMINE HYDROCHLORIDER J General Corporationc46c01c0-29f4-400c-bef5-14b3eb944c512025-11-17WarningsExact identifier
application number: M012
TYLENOL COLD AND FLUACETAMINPHENR J General Corporationb618877b-9dbc-4ba2-be2c-bf1922c646cc2025-11-17WarningsExact identifier
application number: M012
TYLENOL SINUS SEVEREACETAMINOPHENR J General Corporation2cbf7954-b28f-4d7b-b142-6c6c5c58b25d2025-11-17WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRR J General Corporation8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc2025-11-17WarningsExact identifier
application number: M012
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQUALITY CHOICE (Chain Drug Marketing Association)c0e3c959-bed6-2ce5-e053-2995a90a0be92025-11-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpc5ea5a7a-c806-e5e0-e053-2995a90a15e92025-11-17WarningsExact identifier
application number: M012
Multi-Symptom Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED50f3157b-5788-4b63-835a-e60c8dc33df92025-11-17WarningsExact identifier
application number: M012
Day and Night SinusACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inca9d809f5-63a1-4f80-8b4d-33e8e052c7bd2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company937b481a-e0b7-4d34-a8a1-0bfb2b867c2b2025-11-15WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.f701a6ae-200d-48dc-94e4-6bd3228f50d42025-11-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN8eab9d79-69c1-44b8-9145-a7ebd887d54d3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD8eab9d79-69c1-44b8-9145-a7ebd887d54d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-087-01638680087011 BOTTLE, PLASTIC in 1 CARTON (63868-087-01) / 100 CAPSULE in 1 BOTTLE, PLASTIC2008-11-100000-00-00NoNoCurrent
63868-087-24638680087242 BLISTER PACK in 1 CARTON (63868-087-24) / 12 CAPSULE in 1 BLISTER PACK2 blister pack2008-11-102027-04-30NoNoCurrent