FDA.reportPublic FDA data

childrens Allergy Dye Free Wal Dryl

Product NDC
0363-0710
11-digit product format
003630710
Labeler code
0363
Product ID
0363-0710_446b34c1-f13a-24dd-e063-6294a90a4e79
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
WALGREEN CO.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
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
childrens Allergy Dye Free Wal Dryl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049906Internal RxNorm lookup
1086767Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e64e040-1662-4dc9-b33f-3e119e0b3f7bAvailable 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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0710-08childrens Allergy Dye Free Wal Dryl1 in 1 CARTONLIQUID18
0363-0710-08childrens Allergy Dye Free Wal Dryl236 mL in 1 BOTTLELIQUID2368

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0710-08ML - Milliliter0363-0710200f567e-e0a0-461d-a87e-c02f634fed2312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0710CHILDRENS ALLERGY DYE FREE WAL DRYL (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]7Current NDC, Legacy NDC, 2 package rows20241113_4e64e040-1662-4dc9-b33f-3e119e0b3f7b.zip

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 44 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacyeafd9823-c0ad-454a-b725-562d88ebec922026-03-23WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db0470b-1bf0-9137-e063-6394a90a1d542026-03-23WarningsExact identifier
application number: M012
Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db066d4-ddbe-ddce-e063-6394a90ac5f82026-03-23WarningsExact identifier
application number: M012
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola Ag27487e5c-044c-41eb-865f-2f34351afd522026-03-23WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)f288eeca-9803-4962-a802-fe34f5983c7a2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola Agd63b4d24-e926-418c-bb17-420aeaad5a622026-03-23WarningsExact identifier
application number: M012
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6e7dfee1-3de9-46c8-9b58-83fcf8ee72e02026-03-23WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESINHyvee Inc44eafc83-8e7b-89b8-e063-6394a90ab0bc2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola USA Inc.5d7889b1-3866-49b0-97e1-1e883a52d3cb2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola USA Inc.1487652c-dbc1-40f4-9d59-891ec74cc3632026-03-23WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4e2a8b53-0074-42fd-8357-a39cc6afe6082026-03-23WarningsExact identifier
application number: M012
Mucus Relief Severe Cold Daytime Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET Corporation5ccaf3b0-096a-4644-9c6e-9f251c167b3c2026-03-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4d88180f-610c-d9ab-e063-6394a90a09f02026-03-21WarningsExact identifier
application number: M012
Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHyVee Inccc371bc3-ba7a-430d-9ee4-22e9c50935f12026-03-20WarningsExact identifier
application number: M012
Daytime Nighttime Multi Symptom Cold ChildrensDEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreensda4c36f5-ec79-4489-bb18-8ddab79c34bd2026-03-20WarningsExact identifier
application number: M012
Sanatos DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEPharmadel LLC3bddcd5a-7776-49ff-e063-6294a90a5dd12026-03-20WarningsExact identifier
application number: M012
VaporizingCAMPHORAmazon.com Services LLC21cfe9cb-5ff5-4331-8358-4d1d9646d6ac2026-03-19Warnings, Adverse reactionsExact identifier
application number: M012
Equate Wild Cherry Throat DropPECTINWalmart4d66547a-b72a-a0ac-e063-6394a90adc712026-03-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATESafeway, Inc.45d44cd2-5187-4a5c-983a-edb1e8eba0b22026-03-19WarningsExact identifier
application number: M012
Sedalmex XL FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBelmora LLCf2edfedf-e06e-4d1b-8c2d-732e08ec113c2026-03-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1086767Wal-Dryl Children's Allergy 12.5 MG in 5 mL Oral SolutionPSN4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1086767diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Wal-Dryl Childrens]SBD4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1086767Wal-Dryl Children's 12.5 MG per 5 ML Oral SolutionSY4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1086767Wal-Dryl Children's 12.5 MG per 5 ML Prefilled SpoonSY4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1086767Wal-Dryl Children's Allergy 12.5 MG per 5 ML Oral SolutionSY4e64e040-1662-4dc9-b33f-3e119e0b3f7b8
1086767Wal-Dryl Childrens 2.5 MG/ML Oral SolutionSY4e64e040-1662-4dc9-b33f-3e119e0b3f7b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0710-08003630710081 BOTTLE in 1 CARTON (0363-0710-08) / 236 mL in 1 BOTTLE1 bottle2017-08-310000-00-00NoNoCurrent