Allergy Relief

Product NDC
68391-160
11-digit product format
683910160
Labeler code
68391
Product ID
68391-160_3bec0860-3dd2-a992-e063-6294a90a3645
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BJWC (Berkley & Jensen / BJ's)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

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
68391-160-33Allergy Relief600 in 1 BOTTLETABLET, FILM COATED6002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2f32d32e-e92c-ea57-e063-6394a90a4c392
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2f32d32e-e92c-ea57-e063-6394a90a4c392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68391-160-3368391016033600 TABLET, FILM COATED in 1 BOTTLE (68391-160-33) 2025-08-20NoNoCurrent