Home NDC 42452-378 Revalife
Product NDC 42452-378
11-digit product format 424520378
Labeler code 42452
Product ID 42452-378_131dfafb-a223-40a6-ac98-a7cbe8522c9c
Type HUMAN OTC DRUG
Nonproprietary name Topical menthol
Dosage form OINTMENT
Route TOPICAL
Labeler International Nutraceutical Company of America (INCA), LLC
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-01-26
Marketing end 0000-00-00
Substance MENTHOL
Active strength 938 mg/g
NDC exclude flag E
Listing certified through 2018-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42452-378-48 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42452-378-48 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42452-378-48 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42452-378-48 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42452-378-48 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42452-378-48 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42452-378-48 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42452-378-48 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42452-378-48 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42452-378-48 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42452-378-48 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42452-378-48 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42452-378-48 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42452-378-48 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42452-378-48 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 42452-378-48 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 42452-378-48 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 42452-378-48 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 42452-378-48 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 42452-378-48 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 42452-378-48 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 42452-378-48 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42452-378-48 Revalife 1 in 1 CARTON OINTMENT 1 2 42452-378-49 Revalife 85 g in 1 TUBE OINTMENT 85 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MENTHOL ACTIVE INGREDIENT L7T10EIP3A REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 1 ALPHA-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 1 ISOPROPYL PALMITATE INACTIVE INGREDIENT 8CRQ2TH63M REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 1 N-ACETYLGLUCOSAMINE INACTIVE INGREDIENT V956696549 REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42452-378 REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC] 2 Legacy NDC, 2 package rows 20171207_9e4585bc-273f-4e7b-b95e-ff61cde89cd9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 42452-378-48 42452037848 1 in 1 CARTON Historical 42452-378-49 42452037849 85 g in 1 TUBE 85 g Historical