FDA.reportPublic FDA data

Allergy Relief

Product NDC
0904-7533
11-digit product format
009047533
Labeler code
0904
Product ID
0904-7533_3648f1ee-b2d4-41d9-ac39-c8ec482a6e92
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Brand name suffix
Childrens
Listing expiration
2027-12-31

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
0904-7533-15Allergy ReliefChildrens473 mL in 1 BOTTLE, PLASTICSOLUTION4732
0904-7533-20Allergy ReliefChildrens1 in 1 CARTONSOLUTION12
0904-7533-20Allergy ReliefChildrens118 mL in 1 BOTTLE, PLASTICSOLUTION1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7533-15ML - Milliliter0904-75339a50315c-7750-42d7-84ac-7f09c1a81c8412025-09-12
0904-7533-20ML - Milliliter0904-75337db0e55c-1da3-4658-bdd6-212267bfd44112025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7533ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) SOLUTION [MAJOR PHARMACEUTICALS]1Current NDC, 3 package rows20250309_3a976e90-c6af-4414-984e-9987158c9e98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3a976e90-c6af-4414-984e-9987158c9e982
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3a976e90-c6af-4414-984e-9987158c9e982
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3a976e90-c6af-4414-984e-9987158c9e982
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3a976e90-c6af-4414-984e-9987158c9e982
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3a976e90-c6af-4414-984e-9987158c9e982
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN60587987-c303-4617-ba96-c518ab2a06501
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD60587987-c303-4617-ba96-c518ab2a06501
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY60587987-c303-4617-ba96-c518ab2a06501
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY60587987-c303-4617-ba96-c518ab2a06501
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY60587987-c303-4617-ba96-c518ab2a06501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7533-1500904753315473 mL in 1 BOTTLE, PLASTIC (0904-7533-15) 473 ml2025-03-07NoNoHistorical
0904-7533-20009047533201 BOTTLE, PLASTIC in 1 CARTON (0904-7533-20) / 118 mL in 1 BOTTLE, PLASTIC2025-03-07NoNoHistorical