Home NDC 50991-222-45 Poly Hist PD
Product NDC 50991-222
Requested package NDC 50991-222-45
11-digit product format 509910222
Labeler code 50991
Product ID 50991-222_b4c97c74-25ad-f9f9-e053-2995a90ac7a4
Type HUMAN OTC DRUG
Nonproprietary name thonzylamine hydrochloride and chlophedianol hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Poly Pharmaceuticals, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-07-01
Marketing end 0000-00-00
Substance CHLOPHEDIANOL HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE
Active strength 6 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
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 CHLOPHEDIANOL HYDROCHLORIDE ACTIVE INGREDIENT 69QQ58998Y POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 THONZYLAMINE HYDROCHLORIDE ACTIVE INGREDIENT 6K9YKD48Y4 POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 CHLOPHEDIANOL ACTIVE MOIETY 42C50P12AP POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 THONZYLAMINE ACTIVE MOIETY R79646H5Z8 POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 AMMONIUM GLYCYRRHIZATE INACTIVE INGREDIENT 3VRD35U26C POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50991-222-45 50991022245 45 mL in 1 BOTTLE (50991-222-45) 45 ml 2013-07-01 2022-03-31 No No Current