Menstrual Relief

Product NDC
55315-183
11-digit product format
553150183
Labeler code
55315
Product ID
55315-183_3503b71d-1ed4-45a8-b786-e96250ce2978
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine and Pyrilamine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Freds Inc
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-10-15
Marketing end
2021-12-30
Substance
ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Active strength
500 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55315-183DDiscontinued by firm2026-11-03
excluded packagepackage55315-18355315-183-24DDiscontinued by firm2026-11-03

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 · 24 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 packagepackage55315-183-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55315-183-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55315-183-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55315-183-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55315-183-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55315-183-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55315-183-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55315-183-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55315-183-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55315-183-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55315-183-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55315-183-24557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
CAFFEINEACTIVE INGREDIENT3G6A5W338EMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZAMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
CAFFEINEACTIVE MOIETY3G6A5W338EMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
PYRILAMINEACTIVE MOIETYHPE317O9TLMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [FREDS INC]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-183-24553150183242 BLISTER PACK in 1 CARTON (55315-183-24) > 12 TABLET in 1 BLISTER PACK2 blister pack2012-10-152021-12-30NoNoCurrent