Acetaminophen Phenylephrine HCl

Product NDC
69168-261
11-digit product format
691680261
Labeler code
69168
Product ID
69168-261_a1a8c1b0-1c3d-4d32-b505-e92a19623f65
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500mg Phenylephrine HCl 5mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-12-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-261-992020-01-31C16284748780-19d75b9cf-e32a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-261-99Acetaminophen Phenylephrine HCl23437 in 1 CARTONTABLET234371

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-261ACETAMINOPHEN PHENYLEPHRINE HCL (ACETAMINOPHEN 500MG PHENYLEPHRINE HCL 5MG) TABLET [ALLEGIANT HEALTH]1Legacy NDC, 1 package rows20141202_a1a8c1b0-1c3d-4d32-b505-e92a19623f65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101534acetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSNa1a8c1b0-1c3d-4d32-b505-e92a19623f651
1101534acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa1a8c1b0-1c3d-4d32-b505-e92a19623f651
1101534APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYa1a8c1b0-1c3d-4d32-b505-e92a19623f651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69168-261-996916802619923437 in 1 CARTONHistorical