Midol PM

Product NDC
0280-8070
11-digit product format
002808070
Labeler code
0280
Product ID
0280-8070_d46aa808-0610-0946-e053-2995a90ac33f
Type
HUMAN OTC DRUG
Nonproprietary name
Midol PM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-12-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE
Active strength
500 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0280-8070DDiscontinued by firm2026-10-05
excluded packagepackage0280-80700280-8070-20DDiscontinued 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 · 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 packagepackage0280-8070-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0280-8070-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0280-8070-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0280-8070-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0280-8070-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0280-8070-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0280-8070-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0280-8070-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0280-8070-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0280-8070-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0280-8070-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0280-8070-20557ba5c1ecfa…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
0280-8070-20EA - Each0280-8070cf30ed3e-1ce7-4493-b279-babecf191fa412016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209MIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIDOL PM TABLET, COATED [BAYER HEALTHCARE LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0280-8070-20002808070201 BOTTLE, PLASTIC in 1 CARTON (0280-8070-20) > 20 TABLET, COATED in 1 BOTTLE, PLASTIC2014-12-150000-00-00NoNoCurrent