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 7 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRCVS PHARMACY035c5e2a-04e3-490b-8f1a-233a5cb6eadb2026-08-19WarningsExact identifier
application number: M012
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories89752c69-25c8-45e3-9021-f81b35b52d362026-08-19WarningsExact identifier
application number: M012
CVS Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY3148f80f-8a0d-4b6c-85be-79085fc044442026-08-19WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationaa7164a7-f842-457d-abee-0740bb8c1c902026-08-19WarningsExact identifier
application number: M012
CVSCHILDRENS STUFFY NOSE AND COLDCVS PHARMACY, INC6cff265d-94a3-4617-a366-fe970d97f05a2026-08-19WarningsExact identifier
application number: M012
CVS Severe Congestion and Pain ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS5a8e4320-bae1-4831-b66b-9babfe8888d62026-08-19WarningsExact identifier
application number: M012
CVS Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCVS PHARMACY0ae0c244-e019-4b35-890c-8e15e3d3f7ce2026-08-19WarningsExact identifier
application number: M012
CVS Severe Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACYe32881f5-2bb5-4756-aa86-a09473ab590b2026-08-19WarningsExact identifier
application number: M012
Good Sense Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINL. Perrigo Companyd2541ef0-a73c-43aa-91ff-fdbce2748c4f2026-08-18WarningsExact identifier
application number: M012
CVS Severe Nasal Congestion Relief Clear and CoolOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.5a7e42ee-810c-4bc1-9d8d-fac8e849e1262026-08-18WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC8dd039b4-209a-484a-b15e-741d55087a932026-08-18WarningsExact identifier
application number: M012
CVS Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLCVS PHARMACY558b7ed6-a9f6-452c-90cd-df8258663bf12026-08-18WarningsExact identifier
application number: M012
Extra Strength NasalPHENYLEPHRINE HYDROCHLORIDECVS PHARMACY7acf1a9a-bd97-48bb-8025-ac26070378a22026-08-18WarningsExact identifier
application number: M012
Polytussin DMDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATEPoly Pharmaceuticals, Inc.fda8f594-82bf-1781-e053-6294a90ad3442026-08-18WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCda1f1ef9-a974-4998-8e1d-c1d9995969432026-08-18WarningsExact identifier
application number: M012
CVS Health Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.89168715-71b1-424e-8dae-fcfa90bc85bf2026-08-18WarningsExact identifier
application number: M012
CVS Health SinusOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.c7840511-3a4f-4547-ae90-19b085a5874e2026-08-17WarningsExact identifier
application number: M012
CVS HealthNASAL OXYMETAZOLINE HCLCVS Pharmacy,Inc.56f08e70-bf16-4933-97bc-177bc190d12a2026-08-17WarningsExact identifier
application number: M012
CVS Health No DripALLERGY NASALCVS PHARMACY,INC.3e76ffac-07a7-4b6a-bc4c-9cabb653e0642026-08-17WarningsExact identifier
application number: M012
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsExact 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