FDA.reportPublic FDA data

Poly-Tussin AC

Product NDC
50991-723
11-digit product format
509910723
Labeler code
50991
Product ID
50991-723_efbb79b0-5f44-7ada-e053-2995a90ae470
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine Maleate, Codeine Phosphate, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Poly Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-02
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], alpha-1 Adrenergic Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50991-723DDiscontinued by firm2026-09-14
excluded packagepackage50991-72350991-723-15DDiscontinued by firm2026-09-14
excluded packagepackage50991-72350991-723-16DDiscontinued by firm2026-09-14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-723-16ML - Milliliter50991-723974267a0-0f9c-4f5e-a9cb-c4d3379911d212014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03POLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6POLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4POLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3POLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4POLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RPOLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-723POLY-TUSSIN AC (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]8Legacy NDC20240711_41c354cd-5e98-47ac-a81b-9c3915924c93.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50991-723-155099107231512 BOTTLE, PLASTIC in 1 TRAY (50991-723-15) > 15 mL in 1 BOTTLE, PLASTIC2014-06-020000-00-00NoNoCurrent
50991-723-1650991072316473 mL in 1 BOTTLE (50991-723-16) 473 ml2014-06-020000-00-00NoNoCurrent