ALLERGY RELIEF

Product NDC
49483-061
11-digit product format
494830061
Labeler code
49483
Product ID
49483-061_385f6471-a79e-0c48-e063-6294a90af1a3
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-05-01
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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-061-01ALLERGY RELIEF100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10010
49483-061-10ALLERGY RELIEF1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100010
49483-061-42ALLERGY RELIEF24 in 1 BOTTLETABLET, FILM COATED2410
49483-061-42ALLERGY RELIEF1 in 1 CARTONTABLET, FILM COATED110
49483-061-62ALLERGY RELIEF650 in 1 BOTTLETABLET, FILM COATED65010
49483-061-65ALLERGY RELIEF365 in 1 BOTTLETABLET, FILM COATED36510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-061ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]9Current NDC, Legacy NDC, 6 package rows20250212_7aee34b5-1583-4a8a-8ffb-b17ef2722ac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN7aee34b5-1583-4a8a-8ffb-b17ef2722ac110
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD7aee34b5-1583-4a8a-8ffb-b17ef2722ac110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-061-0149483006101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-01) 2018-12-170000-00-00NoNoCurrent
49483-061-10494830061101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-10) 2018-12-170000-00-00NoNoCurrent
49483-061-42494830061421 BOTTLE in 1 CARTON (49483-061-42) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-30NoNoCurrent
49483-061-6249483006162650 TABLET, FILM COATED in 1 BOTTLE (49483-061-62) 2012-05-010000-00-00NoNoCurrent
49483-061-6549483006165365 TABLET, FILM COATED in 1 BOTTLE (49483-061-65) 2022-02-21NoNoCurrent