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 18 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus CongestionPHENYLEPHRINE HCLL.N.K. International, Inc.81f0276a-99a2-4a57-a0d8-224735aa8c792026-07-10WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN, PHENYLEPHRINE HCLRite Aid Corporationefaf3be1-ab39-45f7-a45c-7fea8705c8d02026-07-10WarningsExact identifier
application number: M012
Equate Daytime Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.f847d9f2-aa47-4bbe-8f06-19356c6373982026-07-10WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLTopco Associates, LLC2a80fba9-5e30-4ec0-bd8e-8957c0654b6c2026-07-10WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50230cad-3d04-8882-e063-6294a90acf3c2026-07-09WarningsExact identifier
application number: M012
Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLRugby Laboratoriesfc42e97d-1224-4d29-a55d-1a1885e0bf8f2026-07-09WarningsExact identifier
application number: M012
Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader7418d92d-a540-40d6-91d0-b7eb1f87f8ff2026-07-08WarningsExact identifier
application number: M012
DG HEALTH COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d2026-07-08WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLCbfcabe02-7961-4407-a748-8cd0877313982026-07-08WarningsExact identifier
application number: M012
Aller-chlorCHLORPHENIRAMINE MALEATERugby Laboratories04ca3806-72be-47d4-9fea-5b0dee0876832026-07-08WarningsExact identifier
application number: M012
nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED24c22c9f-0c2f-46dc-850e-ed05f00d3e952026-07-08WarningsExact identifier
application number: M012
NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.0e65c5d1-a18b-452c-9be6-8d44d34577e92026-07-08WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATECardinal Health 110, LLC. DBA Leaderaaecfda5-1a50-4d8a-9909-7153c1a22bda2026-07-08WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7cb9f378-5d64-475f-bf26-4058ba6c15b42026-07-08WarningsExact identifier
application number: M012
DG HEALTH DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Incf174d08e-3335-4cc9-8766-4070f18c4f312026-07-08WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGHealth Pharma USA LLCd60a3e9d-e88e-3b19-e053-2995a90a3e8d2026-07-07WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLCd38f47ea-7fda-170b-e053-2995a90adc822026-07-07WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsExact identifier
application number: M012
Cold and Flu Severe Day Time / Night TimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCacdcc6ce-c190-4de6-b126-62fe9043112e2026-07-07WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC471b1a43-1708-8be7-e063-6394a90a9bb72026-07-06WarningsExact 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