Allergy Relief

Product NDC
81522-109
11-digit product format
815220109
Labeler code
81522
Product ID
81522-109_24999d88-1a63-7029-e063-6394a90ad4a9
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
FSA STORE INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-11
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
81522-109-03Allergy Relief1 in 1 CARTONTABLET, COATED13
81522-109-03Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-109ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FSA STORE INC.]3Current NDC, Legacy NDC, 2 package rows20241018_ec6aef90-ece1-4fe6-e053-2995a90a9310.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNec6aef90-ece1-4fe6-e053-2995a90a93103
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDec6aef90-ece1-4fe6-e053-2995a90a93103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81522-109-03815220109031 BOTTLE, PLASTIC in 1 CARTON (81522-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2023-01-110000-00-00NoNoCurrent