Home NDC 31774-8005 LaBella Linimento Obrero
Product NDC 31774-8005
11-digit product format 317748005
Labeler code 31774
Product ID 31774-8005_12bf2514-2813-46c3-a3b4-c3425cbeb162
Type HUMAN OTC DRUG
Nonproprietary name Capsaicin, Menthol, Unspecified Form, and Methyl Salicylate
Dosage form CREAM
Route TOPICAL
Labeler Golden Sun Inc DBA Newhall Laboratories
Application part346
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-01-02
Marketing end 0000-00-00
Substance CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength 0 mg/mL; mg/mL; mg/mL
NDC exclude flag E
Listing certified through 2017-12-31
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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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 31774-8005-1 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.
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 31774-8005-1 LaBella Linimento Obrero 236 mL in 1 BOTTLE, PLASTIC CREAM 236 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Capsaicin ACTIVE INGREDIENT S07O44R1ZM LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Menthol, Unspecified Form ACTIVE INGREDIENT L7T10EIP3A LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Methyl Salicylate ACTIVE INGREDIENT LAV5U5022Y LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Capsaicin ACTIVE MOIETY S07O44R1ZM LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Menthol, Unspecified Form ACTIVE MOIETY L7T10EIP3A LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Salicylic Acid ACTIVE MOIETY O414PZ4LPZ LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Edetate Sodium INACTIVE INGREDIENT MP1J8420LU LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Isopropyl Palmitate INACTIVE INGREDIENT 8CRQ2TH63M LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Sorbitan Sesquioleate INACTIVE INGREDIENT 0W8RRI5W5A LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Water INACTIVE INGREDIENT 059QF0KO0R LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31774-8005 LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] 1 Legacy NDC, 1 package rows 20151110_fc5abe34-edf6-400a-bd28-1aea8bac8c70.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 31774-8005-1 31774800501 236 mL in 1 BOTTLE, PLASTIC 236 ml Historical