RockSauce ICY COLD PAIN RELIEF

Product NDC: 81683-003
Requested package NDC: 81683-003-01
11-digit product format: 816830003
Labeler code: 81683
Product ID: 81683-003_3239950d-8958-aaaa-e063-6394a90a8fa2
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Implus Footcare, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-18
Substance: MENTHOL
Active strength: 8.3 g/88.5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81683-003	81683-003-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81683-003	81683-003-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81683-003	81683-003-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: RockSauce ICY COLD PAIN RELIEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	8.3 g/88.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bd4fdff1-9174-31c2-e053-2a95a90a749f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81683-003-01	2025-02-18	C162847	48780-1	2cef2736-6f02-d83d-e063-dadaa90ab31f	81683-003
81683-003-01	2025-01-30	C162847	48780-1	2cef2736-6f02-d83d-e063-dadaa90ab31f	81683-003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81683-003-01	RockSauce ICY COLD PAIN RELIEF	88.5 mL in 1 BOTTLE	GEL	88.5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81683-003	ROCKSAUCE ICY COLD PAIN RELIEF (MENTHOL) GEL [IMPLUS FOOTCARE, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20250409_bd4fdff1-9174-31c2-e053-2a95a90a749f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 101 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CBD Clinic Pain Relief - Level 5	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0ebbc0f-9888-b812-e053-2a95a90a5d3d	2025-01-28	Warnings	Exact identifier application number: M017
CBDMEDIC Arthritis Aches and Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec7255-bb36-41cd-e053-2a95a90aeac4	2025-01-28	Warnings	Exact identifier application number: M017
CBDMEDIC Back and Neck Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec8fc9-c401-5f23-e053-2995a90acb1c	2025-01-28	Warnings	Exact identifier application number: M017
Muscle Therapy	METHYL SALICYLATE, CAMPHOR	Everlaan Organics Inc	0890a683-9a66-fdbd-e063-6294a90ae526	2025-01-27	Warnings	Exact identifier application number: M017
Joint Therapy	CAMPHOR	Everlaan Organics Inc	08904b77-d6db-8b82-e063-6394a90ace4f	2025-01-27	Warnings	Exact identifier application number: M017
Warrior Arthritis Relief	TROLAMIN SALICYLATE 10%	Derma Care Research Labs, LLC	013f48b9-913f-b283-e063-6394a90abd73	2025-01-27	Warnings	Exact identifier application number: M017
DCH Cool and Heat	MENTHOL 16%	Derma Care Research Labs, LLC	ff323282-612c-eaf8-e053-6394a90ab779	2025-01-27	Warnings	Exact identifier application number: M017
Gerigentle	HYDROCORTISONE	GERI-GENTLE CORPORATION	0adfa2f0-9758-5c54-e063-6294a90a461f	2025-01-25	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving	MENTHOL, CAMPHOR	Active and Innovative Inc.	42f1abeb-f6d7-01c3-e054-00144ff88e88	2025-01-23	Warnings	Exact identifier application number: M017
FORTHiQ Pain Relief Lidocaine Patch	PAIN RELIEF LIDOCAINE PATCH	Henan Enokon Medical Instrument Co., Ltd.	2c593420-5788-3422-e063-6394a90a1890	2025-01-22	Warnings	Exact identifier application number: M017
RETALIEF LIDOCAINE 5	LIDOCAINE	Reliable 1 Laboratories LLC	2c262f3c-8cb2-4384-e063-6294a90a436d	2025-01-20	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1c3e5068-dd61-ebdb-e063-6294a90a97cc	2025-01-20	Warnings	Exact identifier application number: M017
PROHEAL BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1	2025-01-19	Warnings	Exact identifier application number: M017
HERSTAT PLUS Cold Sore Treatment	CAMPHOR, MENTHOL	Herstat (USA) Inc.	e20ea714-663d-c4ac-e053-2a95a90a5ecc	2025-01-18	Warnings	Exact identifier application number: M017
Pain Relief Medicated	CAMPHOR MENTHOL METHYL SALICYTATE	RITE AID CORPORATION	60895211-69f3-478b-a33f-1c2071f62950	2025-01-16	Warnings	Exact identifier application number: M017
Elgin Pain Relief	MENTHOL	Eco-Logics, Inc.	70eda21e-e566-42f4-9a49-b0d3ad000652	2025-01-16	Warnings	Exact identifier application number: M017
Curist Lidocaine Patch Maximum Strength	LIDOCAINE	Little Pharma, Inc.	e574c188-cc65-287d-e053-2995a90a5972	2025-01-16	Warnings	Exact identifier application number: M017
Equate Hydrocortisone Topical	HYDROCORTISONE	WalMart	1f64555d-f77e-4a83-b222-fdb3ed7d8853	2025-01-16	Warnings	Exact identifier application number: M017
Equate Hydrocortisone	HYDROCORTISONE	WalMart	f5c32b4a-1159-4b7a-b8ac-256d53020dc2	2025-01-16	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	296fcc36-563f-19ca-e063-6394a90ab3ae	2025-01-15	Warnings	Exact identifier application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81683-003-01	81683000301	88.5 mL in 1 BOTTLE (81683-003-01)	88.5 ml	2021-03-18	0000-00-00	No	No	Current