FDA.reportPublic FDA data

DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
49483-329
11-digit product format
494830329
Labeler code
49483
Product ID
49483-329_7d3b9a35-9e04-4289-e053-2a91aa0a5042
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Time-Cap Labs, Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-03-01
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
DIPHENHYDRAMINE HYDROCHLORIDE
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
49483-329-00DIPHENHYDRAMINE HYDROCHLORIDE100000 in 1 CARTONTABLET, COATED1000002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPDIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-329DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC]2Current NDC, Legacy NDC, 1 package rows20181218_ed899055-0cbb-45bd-92c8-cbef2fc7c361.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNed899055-0cbb-45bd-92c8-cbef2fc7c3612
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDed899055-0cbb-45bd-92c8-cbef2fc7c3612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-329-0049483032900100000 TABLET, COATED in 1 CARTON (49483-329-00) 2018-12-170000-00-00NoNoCurrent