FDA.reportPublic FDA data

Pain Relief

Product NDC
21130-466
11-digit product format
211300466
Labeler code
21130
Product ID
21130-466_bbea4153-0f97-4d3e-93c7-0e3c3d0942a6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Better Living Brands, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-07-26
Marketing end
2026-07-23
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief
Brand name suffix
Non Drowsy Daytime

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 04JA59TNSJ
Rxcui1046378

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-466-08Pain ReliefNon Drowsy Daytime12 in 1 BLISTER PACKTABLET, FILM COATED1212
21130-466-08Pain ReliefNon Drowsy Daytime2 in 1 CARTONTABLET, FILM COATED212

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-466PAIN RELIEF NON DROWSY DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]12Current NDC, Legacy NDC, 2 package rows20241206_fb4d0f19-96bb-4611-9f23-436cf47f6f0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNfb4d0f19-96bb-4611-9f23-436cf47f6f0f12
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDfb4d0f19-96bb-4611-9f23-436cf47f6f0f12
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYfb4d0f19-96bb-4611-9f23-436cf47f6f0f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-466-08211300466082 BLISTER PACK in 1 CARTON (21130-466-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-07-262026-07-23NoNoCurrent