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 73 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
honey lemon cough dropsMENTHOLMeijer5bd35bce-cd85-5314-e053-2991aa0abce62025-12-18WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLMeijer5bd42654-56e5-997e-e053-2a91aa0afd342025-12-18WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLMeijer5bd61cd4-a5ca-9d66-e053-2a91aa0a93a32025-12-18WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLMeijer5bd7c24d-6a61-5d2d-e053-2a91aa0a08ed2025-12-18WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropsMENTHOLMeijer Distribution70e3de9a-1804-ef15-e053-2a95a90a33402025-12-18WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Vanilla HoneyMENTHOLChain Drug Marketing Association, Inc.3d6a4bcc-1044-40f5-928a-378ececcb6872025-12-18WarningsExact identifier
application number: M012
Meijer Strawberry Cough DropsMENTHOLMeijer164de637-e644-711c-e063-6294a90a1c5f2025-12-18WarningsExact identifier
application number: M012
Meijer Severe Menthol Throat DropsMENTHOLMeijer16603ca4-1ce5-2e7e-e063-6394a90ad6f12025-12-18WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLA-S Medication Solutions60587987-c303-4617-ba96-c518ab2a06502025-12-18WarningsExact identifier
application number: M012
NiafluDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC399898f0-e40a-4f5d-e063-6294a90a667d2025-12-17WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLThe Kroget Co.4313a6ce-454d-4c4b-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Menthol cough dropMENTHOLThe Kroger Co.42b257e9-f45e-32c9-e054-00144ff8d46c2025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4318f25a-05d9-2208-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4317f952-a228-0281-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLThe Kroger Co.4316df6e-3ae6-4ab5-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropsMENTHOLThe Kroger Co.43281bd1-f8a7-02a4-e054-00144ff8d46c2025-12-17WarningsExact identifier
application number: M012
Kroger Cherry Cough DropsMENTHOLKrogera2e1d1f5-9b19-1704-e053-2a95a90abb512025-12-17WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CF AdultDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINEMajor Pharmaceuticalsa9958b7d-7060-422b-a098-c1925c2460812025-12-17WarningsExact identifier
application number: M012
Childrens Mucus Relief Cough Cherry LiquidDEXTROMETHORPHAN HBR, GUAIFENSINTopco Associates3170748e-b09f-4c07-9927-df43771166c52025-12-16WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe2025-12-16WarningsExact 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