RockSauce ICY COLD PAIN RELIEF

Product NDC: 81683-003
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81683-003-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81683-003-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81683-003-01	`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 133 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise 3x Medicated Pain Relief Patch	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	164d4d62-00c0-e06d-e063-6294a90abd73	2024-04-17	Warnings	Exact identifier application number: M017
TIGER Balm PAIN RELIEVING HYDROGEL	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	ca601b02-e9be-4d8d-a384-c62553302ceb	2024-04-16	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592a40a-a647-34bd-e063-6394a90a0a10	2024-04-08	Warnings	Exact identifier application number: M017
Menticam	CAMPHOR, MENTHOL, METHYL SALICYLATE	PureTek Corporation	081837a8-9669-be1f-e063-6394a90a9d20	2024-04-05	Warnings	Exact identifier application number: M017
Pain Relieving Liniment	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	97a0c839-0927-4e54-aee2-ded2016ac4a0	2024-04-02	Warnings	Exact identifier application number: M017
HealthWise Capsaicin Heat Patch	CAPSAICIN	Veridian Healthcare	150c1f09-8aa7-67ea-e063-6294a90a950a	2024-04-01	Warnings	Exact identifier application number: M017
HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent	LIDOCAINE HCI	Veridian Healthcare	150d3e54-5c8d-19ef-e063-6394a90a70c2	2024-04-01	Warnings	Exact identifier application number: M017
Meijer Pain Relief Cream	LIDOCAINE	Meijer Distribution	07ecee44-387a-cdce-e063-6294a90ab9c9	2024-03-27	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	141aa2a7-8789-1127-e063-6294a90a2d23	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	1dc21c95-b419-4175-85f8-040b73060d37	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Roll-On Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	d94ae654-ce25-4bff-b9bd-24a0e0e8568a	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	f8bff018-fb4f-47b4-b8f8-4a496aede346	2024-03-20	Warnings	Exact identifier application number: M017
Rugby Arthritis Pain Relieving Topical Analgesic	CAPSAICIN	Rugby Laboratories	8f1bc075-97ac-4154-8768-0d878104c3ba	2024-03-14	Warnings	Exact identifier application number: M017
Rugby Ice Blue External Analgesic	MENTHOL, UNSPECIFIED FORM	Rugby Laboratories	2b65cb6a-4364-4770-b7b9-5c4637edd01a	2024-03-14	Warnings	Exact identifier application number: M017
Leader Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	fd06d17f-4dff-42a9-a84f-904809ceb981	2024-03-13	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	EROS GLOBAL	b3495c95-ba4b-9459-e053-2a95a90a710f	2024-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Exact identifier application number: M017
Pain Reliever Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	130665d6-3de8-cb91-e063-6294a90a2083	2024-03-06	Warnings	Exact identifier application number: M017
Dermachange Aid Anti-Itch	DIPHENHYDRAMINE HCL	Private Label Beauty and Wellness	12ed906c-d028-0ff7-e063-6394a90aaa52	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	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