FDA.reportPublic FDA data

Humco Wintergreen Oil

Product NDC
0395-1667
Requested package NDC
0395-1667-92
11-digit product format
003951667
Labeler code
0395
Product ID
0395-1667_5df25635-32b4-d6f3-e053-2a91aa0a3c21
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate
Dosage form
LIQUID
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1998-03-25
Marketing end
2021-10-31
Substance
METHYL SALICYLATE
Active strength
980 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0395-16670395-1667-92DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-1667-16ML - Milliliter0395-1667a3614f5a-ffff-4afd-9d72-70d535fcd98812014-04-03
0395-1667-92ML - Milliliter0395-1667b2e04fae-b43b-4d5d-9fc7-d5dc670aa8e212014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YHUMCO WINTERGREEN OIL (METHYL SALICYLATE) LIQUID [HUMCO HOLDING GROU, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZHUMCO WINTERGREEN OIL (METHYL SALICYLATE) LIQUID [HUMCO HOLDING GROU, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHUMCO WINTERGREEN OIL (METHYL SALICYLATE) LIQUID [HUMCO HOLDING GROU, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-1667-920039516679259 mL in 1 BOTTLE, GLASS (0395-1667-92) 59 ml2017-11-142021-10-31NoNoCurrent