At One With Nature

Product NDC
54602-011
11-digit product format
546020011
Labeler code
54602
Product ID
54602-011_0db34654-d5f1-468f-b422-c22ccbef396f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 1%
Dosage form
GEL, DENTIFRICE
Route
TOPICAL
Labeler
BIOCARE LABS INC.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-09-18
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54602-011IInactivated by FDA2026-10-16
excluded packagepackage54602-01154602-011-05IInactivated by FDA2026-10-16

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54602-011-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54602-011-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54602-011-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54602-011-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54602-011-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54602-011-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54602-011-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54602-011-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54602-011-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54602-011-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54602-011-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54602-011-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54602-011-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54602-011-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54602-011-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54602-011-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54602-011-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54602-011-05bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54602-011-058dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54602-011-05e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54602-011-059bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54602-011-052020-01-31C16284748780-19d75b9d0-9217-f424-e053-dadaa90a57ceAt One with nature Root Revitalizer for Dry Itchy Scalp

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54602-011-05At One With Nature154 g in 1 CANISTERGEL, DENTIFRICE1541

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
MentholACTIVE MOIETYL7T10EIP3AAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0AT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
CENTAUREA CYANUS FLOWERINACTIVE INGREDIENTQZ239038YCAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OGAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
D&C GREEN NO. 6INACTIVE INGREDIENT4QP5U84YF7AT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
D&C YELLOW NO. 11INACTIVE INGREDIENT44F3HYL954AT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7AT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
HYPERICUM PERFORATUMINACTIVE INGREDIENTXK4IUX8MNBAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
SESAME OILINACTIVE INGREDIENTQX10HYY4QVAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
SULFURINACTIVE INGREDIENT70FD1KFU70AT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
TILIA CORDATA FLOWERINACTIVE INGREDIENTCFN6G1F6YKAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54602-011AT ONE WITH NATURE (MENTHOL 1%) GEL, DENTIFRICE [BIOCARE LABS INC.]1Legacy NDC, 1 package rows20141104_206af367-45c3-4448-ab55-71bc9dcf785c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54602-011-0554602001105154 g in 1 CANISTER154 gHistorical