EFAC

Product NDC
55722-419
11-digit product format
557220419
Labeler code
55722
Product ID
55722-419_9cdba220-6919-4ba3-b6d6-e71d63f01360
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Imagenetix
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
13 mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct55722-419DDiscontinued by firm2026-10-05
excluded packagepackage55722-41955722-419-02DDiscontinued 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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55722-419-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55722-419-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55722-419-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55722-419-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55722-419-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55722-419-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55722-419-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55722-419-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55722-419-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55722-419-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55722-419-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55722-419-02DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55722-419-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55722-419-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55722-419-02IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55722-419-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55722-419-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55722-419-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55722-419-02IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55722-419-022023-03-21C16284748780-19855d018-da72-cd31-e053-dbdaa90ab51aEFAC Pain Relieving Cream
55722-419-022019-11-27C16284748780-19855d018-da72-cd31-e053-dbdaa90ab51aEFAC Pain Relieving Cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
MentholACTIVE MOIETYL7T10EIP3AEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999REFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
WATERINACTIVE INGREDIENT059QF0KO0REFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1