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 96 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	3130729d-1679-90cd-e063-6294a90a21e6	2025-03-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	31314dda-6199-574d-e063-6394a90aae7a	2025-03-25	Warnings	Exact identifier application number: M017
RWSEFK Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	31366793-f8a6-a2c4-e063-6294a90acbfc	2025-03-25	Warnings	Exact identifier application number: M017
Forticept Wounds and Burns Hydrogel	BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Lidan, inc.	c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f	2025-03-25	Warnings	Exact identifier application number: M017
MQ Pain Relieving Patch	PAIN RELIEVING PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0978ff22-c357-e266-e063-6394a90a98a4	2025-03-24	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Advanced Rx of Tennessee, LLC	30c97646-db06-df84-e063-6394a90a7743	2025-03-20	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), PETROLATUM	Carma Laboratories, Inc.	fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57	2025-03-20	Warnings	Exact identifier application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPF	CAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Carma Laboratories, Inc.	5f904369-5f21-4907-98de-df23bce30823	2025-03-20	Warnings	Exact identifier application number: M017
DermaCort Anti-itch	HYDROCORTISONE	Melaleuca, Inc.	24044b0f-dd1e-4762-82b8-7a28b08c2f77	2025-03-20	Warnings	Exact identifier application number: M017
AUVON Lidocaine Menthol Pain Relief Patch	LIDOCAINE AND MENTHOL	SHENZHEN YUWEN E-COMMERCE CO., LTD.	300cf469-5ca2-a40d-e063-6294a90a6801	2025-03-20	Warnings	Exact identifier application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	3a3af6e1-0281-462e-85e7-144cc5d46f32	2025-03-19	Warnings	Exact identifier application number: M017
Lidocaine 4%	LIDOCAINE	Innovida Pharmaeutique Corporation	eb83a3dd-557e-4334-b806-5fc05e9175a3	2025-03-19	Warnings	Exact identifier application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	c04059e9-8175-46c2-8582-f84ef193abd3	2025-03-19	Warnings	Exact identifier application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	3a36a241-37a9-445a-a6e0-97709a7457a8	2025-03-19	Warnings	Exact identifier application number: M017
Herb Analgesic	HERB ANALGESIC PASTE	Changsha Maocheng Trading Co., Ltd	29373587-9eff-6ea0-e063-6394a90a23b2	2025-03-18	Warnings	Exact identifier application number: M017
DEBACHERE Butt Balm After Play Care Multi Symptoms Relief	BENZOCAINE, BENZALKONIUM CHLORIDE	DE.BACHERE USA LLC	f469b446-58a0-4be3-884f-d622b9d074f8	2025-03-17	Warnings	Exact identifier application number: M017
Auvon 4% Menthol Pain Relief Gel	MENTHOL	SHENZHEN YUWEN E-COMMERCE CO., LTD.	2dacd6fe-7d69-bcf0-e063-6294a90a0351	2025-03-14	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	2025-03-14	Warnings	Exact identifier application number: M017
AY BENDITO THERMOACTIVE	MENTHOL, CAMPHOR	AY BENDITO INTERNATIONAL, INC	304d71b6-91c8-b2b6-e063-6394a90ab669	2025-03-14	Warnings	Exact identifier application number: M017
Hot/Cold Medicated Patch	HOT COLD PATCH	Dynarex	999881b3-287e-d975-e053-2995a90a87e3	2025-03-14	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