FDA.reportPublic FDA data

DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
73629-007
11-digit product format
736290007
Labeler code
73629
Product ID
73629-007_47d40763-f19a-a5df-e063-6394a90af7bd
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride capsule, liquid filled
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
AMZ789 LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-18
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73629-007-22DIPHENHYDRAMINE HYDROCHLORIDE220 in 1 BOTTLECAPSULE, LIQUID FILLED2202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73629-007DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED) CAPSULE, LIQUID FILLED [AMZ789 LLC]1Current NDC, 1 package rows20240306_12dd2419-b2e0-5466-e063-6394a90a4221.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN12dd2419-b2e0-5466-e063-6394a90a42212
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD12dd2419-b2e0-5466-e063-6394a90a42212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73629-007-2273629000722220 CAPSULE, LIQUID FILLED in 1 BOTTLE (73629-007-22) 2023-10-18NoNoHistorical