Home NDC 53217-004 New Terocin
Product NDC 53217-004
11-digit product format 532170004
Labeler code 53217
Product ID 53217-004_2d60485d-d6e7-47d7-813d-0db3a3214e20
Type HUMAN OTC DRUG
Nonproprietary name Methyl Salicylate, Capsaicin, and Menthol
Dosage form LOTION
Route TOPICAL
Labeler Aidarex Pharmaceuticals LLC
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-03-13
Marketing end 0000-00-00
Substance METHYL SALICYLATE; CAPSAICIN; MENTHOL
Active strength 25 g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 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 53217-004-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53217-004-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53217-004-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53217-004-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53217-004-01 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53217-004-01 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53217-004-01 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53217-004-01 New Terocin 120 mL in 1 BOTTLE, PLASTIC LOTION 120 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAPSAICIN ACTIVE INGREDIENT S07O44R1ZM NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 METHYL SALICYLATE ACTIVE INGREDIENT LAV5U5022Y NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 CAPSAICIN ACTIVE MOIETY S07O44R1ZM NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 SALICYLIC ACID ACTIVE MOIETY O414PZ4LPZ NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 BORAGE OIL INACTIVE INGREDIENT F8XAG1755S NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 DIMETHYL SULFONE INACTIVE INGREDIENT 9H4PO4Z4FT NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 DMDM HYDANTOIN INACTIVE INGREDIENT BYR0546TOW NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 INDIAN FRANKINCENSE INACTIVE INGREDIENT 4PW41QCO2M NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 IODOPROPYNYL BUTYLCARBAMATE INACTIVE INGREDIENT 603P14DHEB NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 LAVENDER OIL INACTIVE INGREDIENT ZBP1YXW0H8 NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 LIDOCAINE INACTIVE INGREDIENT 98PI200987 NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53217-004 NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 1 package rows 20140214_00b96109-8ece-4531-8182-f5167e9f4632.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53217-004-01 53217000401 120 mL in 1 BOTTLE, PLASTIC 120 ml Historical