FDA.reportPublic FDA data

WALGREENS

Product NDC
0363-2012
11-digit product format
003632012
Labeler code
0363
Product ID
0363-2012_38c863cb-f534-0b3d-e063-6294a90aa8db
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WALGREENS CO.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-09
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 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
WALGREENS
Brand name suffix
Dye Free Chidrens Allergy Chews
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 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
1049900Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
91c369b0-8620-4764-a85d-a86402d9489cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2012-20WALGREENSDye Free Chidrens Allergy Chews10 in 1 BLISTER PACKTABLET, CHEWABLE101
0363-2012-20WALGREENSDye Free Chidrens Allergy Chews2 in 1 CARTONTABLET, CHEWABLE21

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 167 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCb9772292-9eb6-47cf-abb8-007c254780902024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Cough Long-ActingDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC75bc7827-4439-e6a8-a65c-7154d5592e582024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c2024-03-17WarningsExact identifier
application number: M012
ANTIGRIP DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLC12f20aba-f991-bd82-e063-6294a90a4aac2024-03-16WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWALGREENSd3053f80-aece-eb50-e053-2a95a90a59452024-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCLWALGREENSd315bc95-1b46-75df-e053-2a95a90a6c662024-03-15WarningsExact identifier
application number: M012
MAR-COF CG ExpectorantCODEINE PHOSPHATE AND GUAIFENESINMarnel Pharmaceuticals, LLC60a41229-b125-43d8-b2b4-0bf40feed7642024-03-15WarningsExact identifier
application number: M012
Night Time CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INC97aa0b90-1230-4143-b5d3-18b96a6b7b4f2024-03-15WarningsExact identifier
application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLC036162c9-f5a6-418e-bd5e-ebd72097d27d2024-03-15WarningsExact identifier
application number: M012
Bronkaid MaxEPHEDRINE SULFATEFoundation Consumer Healthcare LLC9a0b792a-caee-41f6-9400-922a5ebd592f2024-03-14WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutions5f2b16f0-c58b-4e48-ad92-eaab93c6c4b22024-03-12WarningsExact identifier
application number: M012
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEA-S Medication Solutionsffcae882-0b19-4219-bbee-a175c63d79c82024-03-11WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime with Honey Ginger FlavorACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC18dcede2-5a38-40fa-93fe-48acdd6a7cf12024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime with Honey Elderberry FlavorACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLCd4ce06aa-776f-45e4-a1a6-9cf13797048f2024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC14e38ef0-a5e7-4df7-824f-f27bef664d252024-03-08WarningsExact identifier
application number: M012
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC68d3e88a-d1be-410b-92a1-863903b3aa612024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC0d3b1bea-e2ca-4e07-8ae5-60627d230c962024-03-08WarningsExact identifier
application number: M012
Theraflu PowerPods Daytime Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCe655c33c-c319-41d9-ae55-cf747242cd102024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime Berry BurstACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCadf33520-4689-4de2-b9d8-c201518e9d262024-03-08WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCf6ae9e3a-6bea-40e0-8a6f-45f4be8319e72024-03-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN91c369b0-8620-4764-a85d-a86402d9489c1
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD91c369b0-8620-4764-a85d-a86402d9489c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-2012-20003632012202 BLISTER PACK in 1 CARTON (0363-2012-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2025-06-09NoNoCurrent