FDA.reportPublic FDA data

14803-912-10

Product NDC
14803-912
Requested package NDC
14803-912-10
11-digit product format
148030912
Labeler code
14803
Product ID
14803-912_5cc26063-89f2-f9ae-e063-6294a90a7c7e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride 25
Dosage form
CAPSULE
Marketing category
DRUG FOR FURTHER PROCESSING
Marketing start
2025-09-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage14803-91214803-912-10UNFINISHEDActive or certified unfinished drug listing2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
No
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
14803-912-101480309121048000 CAPSULE in 1 BOX (14803-912-10)48000 capsule03-SEP-25Current