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 84 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Afrin Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.0f5ec576-f788-40aa-9088-0dd672e3cc7c2025-12-04WarningsExact identifier
application number: M012
Adult Long Lasting Cough ReliefDEXTROMETHORPHAN HBRShield Pharmaceuticals Corp432a79a9-c69d-4514-894a-7832e1b745ef2025-12-04WarningsExact identifier
application number: M012
GENCONTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS69d16d25-b09b-430e-8e01-0962d840dc212025-12-04WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLH E B7c04ab14-af28-4598-90ef-56ac11902c7d2025-12-04WarningsExact identifier
application number: M012
Desgen PediatricDEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCLKramer Novis12425c1b-8bdc-446b-83dd-95e05a4d9b8c2025-12-04WarningsExact identifier
application number: M012
Presgen BDEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5befa829-32bd-4978-8a0e-1d6513ff37a42025-12-03WarningsExact identifier
application number: M012
TUSSLINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKramer Novis987e19a5-032f-44e9-b4c7-8a764d5026952025-12-03WarningsExact identifier
application number: M012
DayTime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.450e8974-8ff8-4b82-e063-6394a90a93662025-12-03WarningsExact identifier
application number: M012
Nighttime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTIONLil' Drug Store Products, Inc.4510223f-1c88-2796-e063-6394a90a18ac2025-12-03WarningsExact identifier
application number: M012
Carolina Crud CrusherDEXTROMETHORPHAN HBR, GUAIFENESINWeeks & Leo Co., Inc.0b606683-7d68-cca5-e063-6394a90a6f582025-12-03WarningsExact identifier
application number: M012
Capmist DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECapital Pharmaceutical, LLC63733ac3-859e-4a8e-8717-d852bd3034082025-12-03WarningsExact identifier
application number: M012
ALA-HIST IRDEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.0d203b5c-8b10-428b-8703-17be6b4ce6eb2025-12-03WarningsExact identifier
application number: M012
ALAHIST DMDEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.fdaa062d-110e-798d-e053-6394a90a755c2025-12-03WarningsExact identifier
application number: M012
Alahist DPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.a1b8533a-ef8b-57cc-e053-2995a90a5d9e2025-12-03WarningsExact identifier
application number: M012
Alahist PEDEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.ada2d582-5813-2029-e053-2a95a90ae5672025-12-03WarningsExact identifier
application number: M012
Benadryl Allergy Extra Strength Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC30aca3ab-b091-3939-e063-6294a90a98192025-12-03WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRL.N.K. International, Inc.9f2daffc-1904-4d64-9f84-689c88601e062025-12-03WarningsExact identifier
application number: M012
Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.d291faa9-894e-421c-8115-8a8c2a9371722025-12-03WarningsExact identifier
application number: M012
SINUS PAIN AND CONGESTIONACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS Pharmacy697dffdd-5b56-4395-8e69-6b4360d9fdc52025-12-02WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,9c8c1974-f931-4493-abb5-ecdc32764ab32025-12-02WarningsExact 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