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 91 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DermaD ANTI-ITCH Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	8f4a57cb-0a5b-42b0-a325-1f92f3942ad9	2025-05-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	f7aecfb4-c194-4554-8d05-4e46005e654b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	b679ed7b-9d88-4eff-9743-567affe0fe2b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage Roll On	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	28eb8273-5789-4f33-bbbe-3a5ec7bc7929	2025-05-27	Warnings	Exact identifier application number: M017
AUVON Pain Relief Cream	LIDOCAINE	SHENZHEN YUWEN E-COMMERCE CO., LTD.	358c2632-3b90-1c54-e063-6294a90ad461	2025-05-22	Warnings	Exact identifier application number: M017
WelAhead by Welmate Lidocaine 5% Roll-on	LIDOCAINE 5%	OTC PHARM LLC	0b75e83e-8c7b-6247-e063-6294a90ac413	2025-05-21	Warnings	Exact identifier application number: M017
Bliss Republic	LIDOCAINE NUMBING EXTRA STRENGTH CREAM	Sargass Group Limited Liability Company	35aba13a-95e6-a395-e063-6294a90a5bdc	2025-05-21	Warnings	Exact identifier application number: M017
Xpect Stopain Clinical	MENTHOL	Cintas Corporation	e911478f-7153-4700-b945-92ec54972f45	2025-05-21	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Preferred Pharmaceuticals Inc.	0976a898-8d79-4b85-b473-c8ad32b4fd00	2025-05-20	Warnings	Exact identifier application number: M017
Numbing Cream	LIDOCAINE	100 KARMA INC	359884d6-188a-e503-e063-6294a90acab4	2025-05-20	Warnings	Exact identifier application number: M017
AY BENDITO - THERMOACTIVE	CAMPHOR, MENTHOL	AY BENDITO - THERMOACTIVE LOTION	835abc66-680f-be06-e053-2a91aa0a309e	2025-05-19	Warnings	Exact identifier application number: M017
Numbing Cream	LIDOCAINE	100 KARMA INC	35884644-d017-eda3-e063-6394a90a1f6c	2025-05-19	Warnings	Exact identifier application number: M017
QUIT SMOKING Proven Patches	NICOTINE	Jiashen International Trade Limited	35570155-c769-dc4c-e063-6394a90a019d	2025-05-17	Warnings	Exact identifier application number: M017
VBBV Tattoo Numbing	LIDOCAINE	Jiashen International Trade Limited	3557859e-f8b3-1049-e063-6394a90ad737	2025-05-17	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	35415851-beba-5bb4-e063-6294a90a35c0	2025-05-16	Warnings	Exact identifier application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	352798e1-1e09-3d47-e063-6394a90ad404	2025-05-15	Warnings	Exact identifier application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	35285d62-c660-a056-e063-6294a90aabc8	2025-05-15	Warnings	Exact identifier application number: M017
SionBiotext Hydrocortisone	HYDROCORTISONE ACETATE 1%	Sion Biotext Medical Ltd	35073eae-26fe-2bb5-e063-6294a90ab56a	2025-05-13	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	3508ae14-d9c9-3c85-e063-6294a90a0098	2025-05-13	Warnings	Exact identifier application number: M017
SORE NO MORE WARM THERAPY	MENTHOL AND CAMPHOR	SOMBRA COSMETICS INC.	cd86b56e-9b4c-4aca-9740-c8793cb12055	2025-05-12	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