FDA.reportPublic FDA data

Diphenhydramine HCl Oral Solution

Product NDC
0904-7323
11-digit product format
009047323
Labeler code
0904
Product ID
0904-7323_425e484b-f7c7-4776-8d72-9a5bfb4f6dc5
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-22
Marketing end
2026-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine HCl Oral Solution

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0904-7323-702025-09-05C16284748780-13b156c62-2cc4-fb37-e063-e6dba90a4e07Diphenhydramine HCl Oral Solution 12.5 mg/5 mL Diphenhydramine HCl Oral Solution 25 mg/10 mL
0904-7323-702025-07-29C16284748780-13b156c62-2cc4-fb37-e063-e6dba90a4e07Diphenhydramine HCl Oral Solution 12.5 mg/5 mL Diphenhydramine HCl Oral Solution 25 mg/10 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7323-41Diphenhydramine HCl Oral Solution5 mL in 1 CUP, UNIT-DOSESOLUTION53
0904-7323-70Diphenhydramine HCl Oral Solution100 in 1 BOX, UNIT-DOSESOLUTION1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7323-41ML - Milliliter0904-732347566786-0115-4f2c-a09c-6efe34eb2a5d12024-02-14
0904-7323-70ML - Milliliter0904-73233f6eb9cc-7877-408b-a71d-89c6bd98de2712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7323DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [MAJOR® PHARMACEUTICALS]2Current NDC, 2 package rows20240321_0f9015c9-a95a-5703-e063-6394a90a6ad2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN0f9015c9-a95a-5703-e063-6394a90a6ad23
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD0f9015c9-a95a-5703-e063-6394a90a6ad23
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY0f9015c9-a95a-5703-e063-6394a90a6ad23
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY0f9015c9-a95a-5703-e063-6394a90a6ad23
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY0f9015c9-a95a-5703-e063-6394a90a6ad23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7323-41009047323415 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0904-7323-7000904732370100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (0904-7323-70) / 5 mL in 1 CUP, UNIT-DOSE (0904-7323-41) 2024-01-222026-06-30NoNoHistorical