FDA.reportPublic FDA data

Allergy Relief

Product NDC
0363-6682
11-digit product format
003636682
Labeler code
0363
Product ID
0363-6682_474d5285-63ec-bf7c-e063-6294a90a72db
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride 25mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
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
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
Allergy Relief
Brand name suffix
Dye Free
Listing expiration
2027-12-31

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
36ba3ff2-1965-aa56-e063-6294a90afe17Available 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
0363-6682-24Allergy ReliefDye Free2 in 1 CARTONCAPSULE, LIQUID FILLED22
0363-6682-24Allergy ReliefDye Free12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
0363-6682-48Allergy ReliefDye Free4 in 1 CARTONCAPSULE, LIQUID FILLED42
0363-6682-48Allergy ReliefDye Free12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

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 68 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Menthol Cough DropsMENTHOLWalmart124e6968-f59c-39d4-e063-6294a90a66d42025-12-23WarningsExact identifier
application number: M012
Equate Severe Menthol Throat DropMENTHOLWalmart125f3f5a-52aa-e398-e063-6394a90a00122025-12-23WarningsExact identifier
application number: M012
Equate Menthol Chewable GelsMENTHOLWalmart1ba4b2be-7242-0a23-e063-6294a90af29c2025-12-23WarningsExact identifier
application number: M012
Walgreens Severe Menthol Throat DropsMENTHOLWalgreens21dd3c68-cbc6-4799-e063-6394a90a69722025-12-23WarningsExact identifier
application number: M012
cherry throat relief lozengesBENZOCAINEZee Medical499d0748-538f-678c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINNuCare Pharmaceuticals, Inc.46a480c7-7092-b809-e063-6294a90a60cd2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods360a6304-206d-5475-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods36342d8c-34ab-6178-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLWinco Foods37244333-1307-5121-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco foods37718c73-880e-4a5c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco Foods40676ddc-577f-5cc9-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLWinco Foods3788e8b6-ab9e-1513-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIESeeca6370-29ea-4540-8139-e8461d58a2862025-12-23WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Martdd31f86b-f59e-459a-8e5f-176828706a4a2025-12-23WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf8e7a08e-7422-4a1b-bfec-93e0b50d10cd2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ae97-7951-4058-e053-2995a90a7b2e2025-12-23WarningsExact identifier
application number: M012
Childrens Chest Congestion Relief GrapeGUAIFENESINDiscount Drug Mart3e5d245f-515c-4106-a855-fb97681b646a2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ed16-86bb-3faf-e053-2995a90acfbc2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa7999da7-148a-4c6d-a2ea-0f4cc1d5b2832025-12-23WarningsExact identifier
application number: M012
Safetussin High Blood Pressure and diabetes Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES279e309c-040d-4001-808d-b7d986a9a1d82025-12-23WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN36ba3ff2-1965-aa56-e063-6294a90afe172
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD36ba3ff2-1965-aa56-e063-6294a90afe172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-6682-24003636682242 BLISTER PACK in 1 CARTON (0363-6682-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-06-01NoNoCurrent
0363-6682-48003636682484 BLISTER PACK in 1 CARTON (0363-6682-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2025-06-01NoNoCurrent