Allergy

Product NDC
53943-113
11-digit product format
539430113
Labeler code
53943
Product ID
53943-113_24ada091-b461-930f-e063-6394a90a0a3d
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-11-30
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
Listing expiration
2026-12-31

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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-113-01Allergy12 in 1 BLISTER PACKCAPSULE123
53943-113-01Allergy2 in 1 CARTONCAPSULE23
53943-113-03Allergy1 in 1 CARTONCAPSULE13
53943-113-03Allergy100 in 1 BOTTLE, PLASTICCAPSULE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-113ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [DISCOUNT DRUG MART]3Current NDC, Legacy NDC, 4 package rows20241019_4d93a703-c905-4fb3-b772-11c207065d4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4d93a703-c905-4fb3-b772-11c207065d4d3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4d93a703-c905-4fb3-b772-11c207065d4d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-113-01539430113012 BLISTER PACK in 1 CARTON (53943-113-01) / 12 CAPSULE in 1 BLISTER PACK2 blister pack2007-11-300000-00-00NoNoCurrent
53943-113-03539430113031 BOTTLE, PLASTIC in 1 CARTON (53943-113-03) / 100 CAPSULE in 1 BOTTLE, PLASTIC2007-11-300000-00-00NoNoCurrent