ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
49035-026
11-digit product format
490350026
Labeler code
49035
Product ID
49035-026_90074711-62ce-445f-8682-19639b60b3ff
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WALMART STORES INC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-026-202020-01-31C16284748780-19d75b9d0-7c2a-f424-e053-dadaa90a57ceACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS
49035-026-502020-01-31C16284748780-19d75b9d0-7c2a-f424-e053-dadaa90a57ceACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-026-20ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1001
49035-026-20ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE2 in 1 CARTONTABLET, FILM COATED21
49035-026-50ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED11
49035-026-50ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE50 in 1 BOTTLETABLET, FILM COATED501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-026ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [WALMART STORES INC]1Legacy NDC, 4 package rows20140601_778465c5-6606-4e3a-bb7b-7a4dcebf15c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN778465c5-6606-4e3a-bb7b-7a4dcebf15c51
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD778465c5-6606-4e3a-bb7b-7a4dcebf15c51
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY778465c5-6606-4e3a-bb7b-7a4dcebf15c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49035-026-2049035002620100 in 1 BOTTLEHistorical
49035-026-50490350026501 in 1 CARTONHistorical