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 100 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NyQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Company724d0889-5ba5-3125-e053-2a91aa0a92c12025-10-01WarningsExact identifier
application number: M012
DayQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company724f2833-34bd-6a9e-e053-2991aa0a073d2025-10-01WarningsExact identifier
application number: M012
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEInvaTech Pharma Solutions LLCb8d360fa-0d80-f6a8-e053-2a95a90a8bd42025-10-01Exact identifier
application number: M012
LEADER TUSSIN CFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderf4ffe87b-0a62-44ac-b84a-08cf77cda7f52025-10-01WarningsExact identifier
application number: M012
Nasal Spray, 1oz, 24/7 Life by 7-ElevenOXYMETAZOLINE HCL NASAL SOLUTION 0.05%Lil' Drug Store Products, Inc.3e781417-9ffc-f2c9-e063-6294a90a72052025-09-30WarningsExact identifier
application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf2025-09-30WarningsExact identifier
application number: M012
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3ff240ba-90b2-4c17-e063-6394a90ac56f2025-09-29WarningsExact identifier
application number: M012
DometussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc3fcace53-a81f-e774-e063-6294a90a32fa2025-09-27WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf6a3680a-3ac6-4fd4-be52-ce29064c4aa12025-09-26WarningsExact identifier
application number: M012
No Drip Severe Nasal MistOXYMETAZOLINE SPRAYCVS Health9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae52025-09-26WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa0b3be-2124-ed1d-e063-6294a90aaf482025-09-25WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3fa17255-514f-db47-e063-6294a90ae4542025-09-25WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa17272-fd7f-9ab4-e063-6394a90a585f2025-09-25WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa2e438-2ff3-a2df-e063-6394a90ac7b52025-09-25WarningsExact identifier
application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANTGUAIFENESINQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63dad603-fe2f-42a6-a626-5c8048a42c102025-09-25WarningsExact identifier
application number: M012
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHealth Pharma USA LLCa03befb4-d86d-43e4-8097-eda5c8bb25be2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f8d7d47-f14c-888c-e063-6394a90a5cdd2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
application number: M012
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories, Inc3f79137f-f0b0-d22c-e063-6394a90a72452025-09-23WarningsExact 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