DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
35916-0470
11-digit product format
359160470
Labeler code
35916
Product ID
35916-0470_47c5c74b-1c7b-fdd7-e063-6394a90a86f0
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Softgel Healthcare Pvt Ltd
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-22
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
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
DIPHENHYDRAMINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0470-1DIPHENHYDRAMINE HYDROCHLORIDE1000 in 1 BAGCAPSULE, LIQUID FILLED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35916-0470DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]1Current NDC, 1 package rows20250427_335b09c6-ee5d-ebdf-e063-6294a90abd12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN335b09c6-ee5d-ebdf-e063-6294a90abd122
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD335b09c6-ee5d-ebdf-e063-6294a90abd122
1020477diphenhydramine HCl 50 MG Oral CapsuleSY335b09c6-ee5d-ebdf-e063-6294a90abd122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
35916-0470-1359160470011000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0470-1) 2025-04-22NoNoCurrent