TIME-GESIC

Product NDC
49483-356
11-digit product format
494830356
Labeler code
49483
Product ID
49483-356_97f18e17-9dda-8bf7-e053-2995a90ae67b
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Time-Cap Labs, Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-12-18
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
49483-356-00TIME-GESIC100000 in 1 CARTONTABLET, COATED1000005
49483-356-09TIME-GESIC90 in 1 BOTTLE, PLASTICTABLET, COATED905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
POVIDONEINACTIVE INGREDIENTFZ989GH94ETIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-356TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC]5Legacy NDC, 2 package rows20191123_889c5b6a-879e-425c-a25a-435766e9d601.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052462acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG Oral TabletPSN889c5b6a-879e-425c-a25a-435766e9d6015
1052462acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Oral TabletSCD889c5b6a-879e-425c-a25a-435766e9d6015
1052462APAP 325 MG / diphenhydramine hydrochloride 12.5 MG Oral TabletSY889c5b6a-879e-425c-a25a-435766e9d6015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-356-0049483035600100000 TABLET, COATED in 1 CARTON (49483-356-00) 2012-12-180000-00-00NoNoCurrent
49483-356-094948303560990 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-356-09) 2012-12-180000-00-00NoNoCurrent