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 125 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	070000d7-7d4d-439b-9a91-851ba7c027e6	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone anti itch	HYDROCORTISONE	H E B	a1a9fed8-4938-48b5-81f1-d3942d534bb8	2024-10-03	Warnings	Exact identifier application number: M017
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	ef9ea069-9b97-4bf5-aaac-deb85334dbd0	2024-10-03	Warnings	Exact identifier application number: M017
Basic Care Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	7fa13ab4-5f2d-4a48-816f-1b22d5f757b2	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	dc388dc1-0c4f-4bf1-8a12-fa39892317bc	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	fb2beb08-0ad6-a89d-e053-6294a90aa6fe	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular Balm	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	da28097f-4b5c-6159-e053-2a95a90a7d96	2024-10-02	Warnings	Exact identifier application number: M017
Circatrix	CAPSAICIN	PureTek Corporation	cd3b1256-2df8-dc26-e053-2a95a90ad049	2024-10-02	Warnings	Exact identifier application number: M017
DermacinRx Penetral Cream	CAPSAICIN	PureTek Corporation	1e343a52-6071-3230-e054-00144ff8d46c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	36abfc2c-d424-4df8-968d-866342c96a56	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Balm	CAMPHOR MENTHOL	Eagle Indo Pharma, PT	87614869-9675-2c76-e053-2a95a90a48a9	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	d9a93daa-4e24-6690-e053-2a95a90a147c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Extra Strength	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	5e02fbe3-5bc7-430e-b661-3a760ddd8fe0	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Oil Refreshing	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	c62a4313-2c07-5f58-e053-2995a90a083a	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Eagle Indo Pharma, PT	e272ec90-3cd9-5b70-e053-2a95a90a1df4	2024-10-02	Warnings	Exact identifier application number: M017
RUGBY HYDROCORTISONE WITH ALOE	HYDROCORTISONE	A-S Medication Solutions	b2674075-aaa4-4c77-bcaa-a76336b3c321	2024-10-02	Warnings	Exact identifier application number: M017
Herb Street Anti-Itch Stick	HYDROCORTISONE	Balassa Laboratories Inc.	8717faae-59c3-4c6f-9ef1-285c0d2445ed	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Backache and Sore Muscle Relief	MENTHOL	Balassa Laboratories Inc.	aeac1b64-8689-4b3d-a41c-db41061257b5	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Arthritis Relief	MENTHOL/CAMPHOR	Balassa Laboratories Inc.	a9d8ceb7-def0-415f-8fc1-ff8dd3e41855	2024-10-01	Warnings	Exact identifier application number: M017
Lido King Lidocaine 4% Pain Relieving Gel-Patch	LIDOCAINE	Galaxy Bio, Inc.	2243734a-4ea2-a5e5-e063-6294a90aba15	2024-10-01	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