Premsyn pms Premenstrual Syndrome Relief

Product NDC
41167-3102
11-digit product format
411673102
Labeler code
41167
Product ID
41167-3102_6d719c5a-4100-4109-b630-35d2b04d03ff
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Pamabrom and Pyrilamine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Chattem, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-05-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE
Active strength
500 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct41167-3102DDiscontinued by firm2026-10-05
excluded packagepackage41167-310241167-3102-1DDiscontinued by firm2026-10-05
excluded packagepackage41167-310241167-3102-3DDiscontinued by firm2026-10-05

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41167-3102-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41167-3102-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41167-3102-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41167-3102-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41167-3102-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41167-3102-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41167-3102-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41167-3102-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41167-3102-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41167-3102-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41167-3102-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41167-3102-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41167-3102-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41167-3102-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41167-3102-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41167-3102-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41167-3102-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41167-3102-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41167-3102-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41167-3102-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41167-3102-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41167-3102-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41167-3102-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41167-3102-3557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-3102-1EA - Each41167-3102bbcda368-6287-405b-9b06-673fb2fa65f012022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
PAMABROMACTIVE INGREDIENTUA8U0KJM72PREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZAPREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
PAMABROMACTIVE MOIETYUA8U0KJM72PREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
PYRILAMINEACTIVE MOIETYHPE317O9TLPREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREMSYN PMS PREMENSTRUAL SYNDROME RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [CHATTEM, INC.]2