DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
68210-5057
11-digit product format
682105057
Labeler code
68210
Product ID
68210-5057_474d365f-143c-8019-e063-6294a90ab3ea
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Prodose, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DIPHENHYDRAMINE HYDROCHLORIDE
Listing expiration
2026-12-31

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
68210-5057-1DIPHENHYDRAMINE HYDROCHLORIDE2 in 1 BOXCAPSULE, LIQUID FILLED22
68210-5057-1DIPHENHYDRAMINE HYDROCHLORIDE3000 in 1 POUCHCAPSULE, LIQUID FILLED30002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3b1ea33b-8460-31cf-e063-6394a90a55342
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3b1ea33b-8460-31cf-e063-6394a90a55342
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3b1ea33b-8460-31cf-e063-6394a90a55342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68210-5057-1682105057012 POUCH in 1 BOX (68210-5057-1) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH2 pouch2025-07-30NoNoHistorical