FDA.reportPublic FDA data

Allergy Relief

Product NDC
0363-1900
11-digit product format
003631900
Labeler code
0363
Product ID
0363-1900_ca35c732-b17b-433d-b162-d4ff5fdd6374
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-17
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
8c4b59b8-dfab-4f4a-9966-f07b026a758aAvailable 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
0363-1900-07Allergy Relief3 in 1 CARTONCAPSULE39
0363-1900-07Allergy Relief12 in 1 BLISTER PACKCAPSULE129
0363-1900-08Allergy Relief2 in 1 CARTONCAPSULE29
0363-1900-08Allergy Relief12 in 1 BLISTER PACKCAPSULE129
0363-1900-12Allergy Relief1 in 1 CARTONCAPSULE19
0363-1900-12Allergy Relief100 in 1 BOTTLE, PLASTICCAPSULE1009
0363-1900-51Allergy Relief365 in 1 BOTTLE, PLASTICCAPSULE3659
0363-1900-78Allergy Relief600 in 1 BOTTLE, PLASTICCAPSULE6009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1900ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [WALGREEN COMPANY]6Current NDC, Legacy NDC, 8 package rows20250104_8c4b59b8-dfab-4f4a-9966-f07b026a758a.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 86 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreen NightTime Cold and Flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWALGREENS CO.6b3766e6-d0d4-49e0-90da-fc893aef33292025-11-25WarningsExact identifier
application number: M012
Adult Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANY586310f3-0014-4cfc-9d86-961b3fb7aa8c2025-11-25WarningsExact identifier
application number: M012
childrens Allergy Dye Free Wal DrylDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.4e64e040-1662-4dc9-b33f-3e119e0b3f7b2025-11-25WarningsExact identifier
application number: M012
WalgreenNASALWALGREENS COd38f8406-d7b9-472c-a472-58968bbdb9932025-11-25WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC780907b8-34ba-4ec8-bcdf-b2a31bd111df2025-11-25WarningsExact identifier
application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCd13efbcd-1277-45d0-8389-1ba0337f7a242025-11-25WarningsExact identifier
application number: M012
Childrens Robitussin Elderberry Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCfe903448-b422-42e0-b05b-aeb3e5481e3c2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC1d4fcb76-22d1-7292-e063-6394a90af9202025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGH Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLCf22248b7-7abd-4df7-a986-dae357ebe8f12025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN Nighttime Cough DM Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC39468746-e06d-4849-9d06-9af4d14351b02025-11-25WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4478fd51-bae3-6108-e063-6394a90a07ca2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.395bb39a-e26f-f4f2-e063-6394a90ae7212025-11-25WarningsExact identifier
application number: M012
day timeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E Beaf3af6a-de5b-43fe-83ff-9641646e0f6b2025-11-25WarningsExact identifier
application number: M012
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid GelsACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERB Health (US) LLC38571853-992f-9998-e063-6394a90a85812025-11-24WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLCe19b561c-fb76-4355-a306-d3dc46930bf22025-11-24WarningsExact identifier
application number: M012
Sinus DecongestionPSEUDOEPHEDRINE HCLKroger Company73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c2025-11-24WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCICardinal Health (Leader) 7000014c507df-fbac-4a09-a66c-b91c2abbf5502025-11-24WarningsExact identifier
application number: M012
Severe Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCIFamily Dollar (FAMILY WELLNESS)e5c90d6e-70aa-4886-bc81-293e0dcf56382025-11-24WarningsExact identifier
application number: M012
Throat Coat Eucalyptus MintMENTHOLTraditional Medicinals, Inc.a7a86f1b-30e8-6f5d-e053-2a95a90a2a822025-11-21WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.4538248f-11cc-d6b2-e063-6294a90a652c2025-11-21WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN8c4b59b8-dfab-4f4a-9966-f07b026a758a9
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD8c4b59b8-dfab-4f4a-9966-f07b026a758a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1900-07003631900073 BLISTER PACK in 1 CARTON (0363-1900-07) / 12 CAPSULE in 1 BLISTER PACK3 blister pack2024-12-30NoNoCurrent
0363-1900-08003631900082 BLISTER PACK in 1 CARTON (0363-1900-08) / 12 CAPSULE in 1 BLISTER PACK2 blister pack2021-09-170000-00-00NoNoCurrent
0363-1900-12003631900121 BOTTLE, PLASTIC in 1 CARTON (0363-1900-12) / 100 CAPSULE in 1 BOTTLE, PLASTIC2025-12-11NoNoCurrent
0363-1900-5100363190051365 CAPSULE in 1 BOTTLE, PLASTIC (0363-1900-51) 365 capsule2021-09-17NoNoCurrent
0363-1900-7800363190078600 CAPSULE in 1 BOTTLE, PLASTIC (0363-1900-78) 600 capsule2025-12-16NoNoCurrent