Home NDC 50991-782-02 ALA-HIST PE
Product NDC 50991-782
Requested package NDC 50991-782-02
11-digit product format 509910782
Labeler code 50991
Product ID 50991-782_b20bf894-89c2-ddad-e053-2a95a90a16cf
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine Hydrochloride, Dexbrompheniramine Maleate
Dosage form TABLET
Route ORAL
Labeler Poly Pharmaceuticals, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-09-15
Marketing end 0000-00-00
Substance PHENYLEPHRINE HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE
Active strength 10 mg/1; mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXBROMPHENIRAMINE MALEATE ACTIVE INGREDIENT BPA9UT29BS ALA-HIST PE (PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ALA-HIST PE (PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.] 4 DEXBROMPHENIRAMINE ACTIVE MOIETY 75T64B71RP ALA-HIST PE (PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ALA-HIST PE (PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.] 4 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP ALA-HIST PE (PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALA-HIST PE (PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ALA-HIST PE (PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALA-HIST PE (PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ALA-HIST PE (PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50991-782-02 50991078202 12 BLISTER PACK in 1 CARTON (50991-782-02) > 1 TABLET in 1 BLISTER PACK 12 blister pack 2011-09-15 0000-00-00 No No Current