Home NDC 43749-310 Avedana Pain Relieving Roll On
Product NDC 43749-310
11-digit product format 437490310
Labeler code 43749
Product ID 43749-310_e362d7b9-9e5e-d240-e053-2a95a90aca72
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route TOPICAL
Labeler Unipack LLC
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-09-29
Marketing end 0000-00-00
Substance CAMPHOR (SYNTHETIC); MENTHOL
Active strength 40 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43749-310-03 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43749-310-03 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43749-310-03 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43749-310-03 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43749-310-03 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43749-310-03 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43749-310-03 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43749-310-03 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43749-310-03 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43749-310-03 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43749-310-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43749-310-03 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43749-310-03 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43749-310-03 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43749-310-03 1332a3947898…d4bfe170f9cd…
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43749-310-03 Avedana Pain Relieving Roll On 89 mL in 1 BOTTLE, WITH APPLICATOR GEL 89 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAMPHOR (SYNTHETIC) ACTIVE INGREDIENT 5TJD82A1ET AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 CAMPHOR (SYNTHETIC) ACTIVE MOIETY 5TJD82A1ET AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 AMINOMETHYLPROPANOL INACTIVE INGREDIENT LU49E6626Q AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 ARNICA MONTANA INACTIVE INGREDIENT O80TY208ZW AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 BOSWELLIA SERRATA RESIN OIL INACTIVE INGREDIENT 5T1XCE6K8K AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 CARBOMER 940 INACTIVE INGREDIENT 4Q93RCW27E AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 ILEX PARAGUARIENSIS LEAF INACTIVE INGREDIENT 1Q953B4O4F AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43749-310 AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK LLC] 6 Legacy NDC, 1 package rows 20220710_59256eea-2a78-4065-82b7-ac81283c2a3e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43749-310-03 43749031003 89 mL in 1 BOTTLE, WITH APPLICATOR (43749-310-03) 89 ml 2017-09-17 0000-00-00 No No Current