FDA.reportPublic FDA data

Dye Free Childrens Allergy Relief

Product NDC
49035-600
11-digit product format
490350600
Labeler code
49035
Product ID
49035-600_42229b75-82a1-aaf8-e063-6394a90a0b15
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
WAL-MART STORES INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-09
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

Additional Listing Data#

Finished product
Yes
Brand name base
Dye Free Childrens Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-600-04Dye Free Childrens Allergy Relief118 mL in 1 BOTTLE, PLASTICSOLUTION1187
49035-600-04Dye Free Childrens Allergy Relief1 in 1 CARTONSOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-600-04ML - Milliliter49035-60042cbc7ef-5fd4-4ac1-a4e2-b37d0c1fd4e312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-600DYE FREE CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC.]6Current NDC, Legacy NDC, 2 package rows20241116_3652ee94-b762-4100-a305-5acbec5f795a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3652ee94-b762-4100-a305-5acbec5f795a7
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3652ee94-b762-4100-a305-5acbec5f795a7
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3652ee94-b762-4100-a305-5acbec5f795a7
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3652ee94-b762-4100-a305-5acbec5f795a7
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3652ee94-b762-4100-a305-5acbec5f795a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-600-04490350600041 BOTTLE, PLASTIC in 1 CARTON (49035-600-04) / 118 mL in 1 BOTTLE, PLASTIC2020-03-090000-00-00NoNoCurrent