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 61 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berkley and Jensen Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINBJWCc15b97a8-968f-4d38-905e-863e9fd16ce62026-01-06WarningsExact identifier
application number: M012
Complete Allergy MedicineDIPHENHYDRAMINE HCLSalado Sales, Inc.c0f5c8ca-b187-40bf-9245-6a29f1c32c972026-01-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leaderc5776b1e-9f72-4a6a-9961-8ac8e05b32492026-01-06WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMajor Pharmaceuticalsf81efbf4-204b-45be-ae32-910d9e4ae4aa2026-01-06WarningsExact identifier
application number: M012
SINUS AND NASAL DECONGESTANTPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd7646859-f996-46cd-a0b9-56b860f609012026-01-05WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLHY-VEE, INC47a71cdf-856d-9ecd-e063-6294a90a70c62026-01-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINOncor Pharmaceuticalsfd35036c-b722-48a3-85fd-60471beb6e742026-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLNuCare Pharmaceuticals,Inc.3c323dc8-f734-b44c-e063-6394a90a61842026-01-05WarningsExact identifier
application number: M012
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLC6bd2b8fd-2023-413b-8988-a47d2058dc852026-01-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWinCo Foods, LLC4c1046df-53a6-4219-83ac-bbf5cf4db9c82026-01-05WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC80323208-9ba5-432b-a8a0-0c0b51e671452026-01-05WarningsExact identifier
application number: M012
Sinus Pressure and Pain PE Maximum StrengthACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation347868e4-0182-4e16-895c-ec269895c57c2026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.c5b11a9c-6d93-4772-93c2-1ef5c56470162026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fae96736-1453-42fe-8158-cde770b231652026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd2026-01-02WarningsExact identifier
application number: M012
Reliable-1 TussinGUAIFENESINRELIABLE 1 LABORATORIES LLC2a33ff82-49df-7aaa-e063-6294a90a12812026-01-02WarningsExact identifier
application number: M012
Tussin DMMaxDEXTROMETHORPHAN HBR, GUAIFENESINRELIABLE 1 LABORATORIES LLCc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa2026-01-02WarningsExact identifier
application number: M012
Severe Sinus Pain and Congestion DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy4af347ce-9745-4a5e-8ce9-e7c97a0a6cc72026-01-02WarningsExact 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