SORE NO MORE WARM THERAPY

Product NDC: 61577-3234
11-digit product format: 615773234
Labeler code: 61577
Product ID: 61577-3234_34f862b6-eefe-92fc-e063-6294a90a5242
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL and CAMPHOR
Dosage form: GEL
Route: TOPICAL
Labeler: SOMBRA COSMETICS INC.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-06-13
Substance: MENTHOL; CAMPHOR (SYNTHETIC)
Active strength: .03; .03 g/g; g/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61577-3234		D	Discontinued by firm	2026-10-20
excluded package	package	61577-3234	61577-3234-2	D	Discontinued by firm	2026-10-20
excluded package	package	61577-3234	61577-3234-3	D	Discontinued by firm	2026-10-20
excluded package	package	61577-3234	61577-3234-4	D	Discontinued by firm	2026-10-20
excluded package	package	61577-3234	61577-3234-5	D	Discontinued by firm	2026-10-20
excluded package	package	61577-3234	61577-3234-6	D	Discontinued by firm	2026-10-20
excluded package	package	61577-3234	61577-3234-7	D	Discontinued by firm	2026-10-20
excluded package	package	61577-3234	61577-3234-9	D	Discontinued by firm	2026-10-20

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 3 · 168 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-3234-4	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-3234-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-3234-7	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-3234-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-3234-6	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-3234-5	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-3234-9	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-3234-4	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-3234-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-3234-7	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-3234-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-3234-6	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-3234-5	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-3234-9	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-4	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-7	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-6	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-7	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-5	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-8	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-3234-9	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-4	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-7	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-6	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-7	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-5	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-8	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-3234-9	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-3234-4	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-3234-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-3234-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-3234-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-3234-7	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-3234-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-3234-6	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-3234-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`

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: SORE NO MORE WARM THERAPY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	.03 g/g
CAMPHOR (SYNTHETIC)	.03 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
5TJD82A1ET	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
630714	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
cd86b56e-9b4c-4aca-9740-c8793cb12055	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61577-3234-2	2025-05-12	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-3	2025-05-12	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-4	2025-05-12	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-5	2025-05-12	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-6	2025-05-12	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-7	2025-05-12	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-8	2025-05-12	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-9	2025-05-12	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-2	2025-01-30	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-3	2025-01-30	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-4	2025-01-30	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-5	2025-01-30	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-6	2025-01-30	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-7	2025-01-30	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-8	2025-01-30	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-9	2025-01-30	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-2	2020-03-06	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-3	2020-03-06	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-4	2020-03-06	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-5	2020-03-06	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-6	2020-03-06	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-7	2020-03-06	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-8	2020-03-06	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-9	2020-03-06	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-2	2020-01-31	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-3	2020-01-31	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-4	2020-01-31	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-5	2020-01-31	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-6	2020-01-31	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-7	2020-01-31	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-8	2020-01-31	Sore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-9	2020-01-31	Sore No More Warm Therapy Natural Pain Relieving Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61577-3234-2	SORE NO MORE WARM THERAPY	907.2 g in 1 BOTTLE, PUMP	GEL	907.2		9
61577-3234-3	SORE NO MORE WARM THERAPY	226.8 g in 1 JAR	GEL	226.8		9
61577-3234-4	SORE NO MORE WARM THERAPY	113.4 g in 1 JAR	GEL	113.4		9
61577-3234-5	SORE NO MORE WARM THERAPY	85 g in 1 BOTTLE, PLASTIC	GEL	85		9
61577-3234-6	SORE NO MORE WARM THERAPY	113.4 g in 1 TUBE	GEL	113.4		9
61577-3234-7	SORE NO MORE WARM THERAPY	56.7 g in 1 JAR	GEL	56.7		9
61577-3234-8	SORE NO MORE WARM THERAPY	28.3 g in 1 PACKAGE	GEL	28.3		9
61577-3234-9	SORE NO MORE WARM THERAPY	5 g in 1 POUCH	GEL	5		9
61577-3234-5	Inflatherm	85 g in 1 BOTTLE, PLASTIC	GEL	85 g	0.03 g in 1g	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61577-3234	SORE NO MORE WARM THERAPY (MENTHOL AND CAMPHOR) GEL [SOMBRA COSMETICS INC.]	9	Current NDC, Legacy NDC, 8 package rows	20250514_cd86b56e-9b4c-4aca-9740-c8793cb12055.zip
61577-3234	INFLATHERM (DICLOFENAC SODIUM AND MENTHOL / CAMPHOR GEL) KIT [V2 PHARMA, LLC]	6	Current NDC, Legacy NDC	20240820_b62f4306-8dbd-4501-8b1e-9aa78f9aee06.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 6 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Non-proprietary name	HEADACHE PATCH	Nanjing 3H Medical Products Co.,Ltd.	586d73f1-0b0b-f596-e063-6394a90a4d57	2026-08-06	Warnings	Exact identifier application number: M017
Point Relief Coldspot Pain Relieving	MENTHOL	Fabrication Enterprises Inc	479fb728-4aeb-42e3-b238-f04255514baa	2026-08-05	Warnings	Exact identifier application number: M017
Dealmed Burn	LIDOCAINE	Dealmed Medical Supplies, LLC.	3b5f7ded-c275-4d7f-9fd4-539797d5507e	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine HCl	LIDOCAINE HCL	Topco Associates LLC	584e1f35-4d99-9c85-e063-6294a90ab3d0	2026-08-05	Warnings, Adverse reactions	Exact identifier application number: M017
Hempe HOT Muscle and Joint Gel	HEMPE	Healthcare International Research Limited	5854a80e-c92b-3ff5-e063-6294a90a2d05	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine Plantar Relief Roll-On	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	585ccb4b-3bff-39b9-e063-6294a90a0e18	2026-08-05	Warnings	Exact identifier application number: M017
Green MARVEL PAIN RELIEF	MENTHOL, CAMPHOR, METHYL SALICYLATE	Miramar Cosmetics, Inc DBA Miramar Lab	9ff6e477-ef79-4a0c-9e21-8cae0e5d8810	2026-08-05	Warnings	Exact identifier application number: M017
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	56e36592-a935-61d4-e063-6294a90a6e4c	2026-08-04	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Menthol Pain Relief	MENTHOL	Carlin Consumer Health LLC	584f5c6e-3385-3221-e063-6294a90aabae	2026-08-04	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	2026-08-04	Warnings	Exact identifier application number: M017
procure	HYDROCORTISONE ACETATE	TWIN MED, LLC	2670c9c4-66ad-40e8-a08a-582b160de39d	2026-08-03	Warnings	Exact identifier application number: M017
Wini By Locsanity Advanced Formula Muscle Joint Relief Balm	METHYL SALICYLATE,CAMPHOR,MENTHOL	Locsanity LLC	5829b5d7-78d4-78a2-e063-6394a90a3dfc	2026-08-03	Warnings	Exact identifier application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Alphamale Delay Cream	BENZOCAINE	Prodigy Media Inc	53d682ee-0802-a16d-e063-6394a90aeee1	2026-07-31	Warnings	Exact identifier application number: M017
Pure Primal Delay Cream	BENZOCAINE	Prodigy Media Inc	57e9e894-c14f-d806-e063-6394a90ab8e5	2026-07-31	Warnings	Exact identifier application number: M017
Satohap	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	df0e2b83-8f61-4ed8-bcc4-55e4ea782090	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	cb000134-92a4-4304-8ef0-0347190e1414	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic Hot	CAPSAICIN	Sato Pharmaceutical Co., Ltd.	16b47cb5-ea5f-4514-9a89-141ee4cc60f8	2026-07-31	Warnings	Exact identifier application number: M017
Satohap Cool and Hot Pads	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceutical Co., Ltd.	b6bf1eab-4ab9-f500-e053-2995a90a8d7b	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
SATOHAP COOL and HOT	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceuticals Co., Ltd.	232a4c76-1a0c-2f4b-e063-6394a90a8849	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
630714	camphor 3 % / menthol 3 % Topical Gel	PSN	cd86b56e-9b4c-4aca-9740-c8793cb12055	9
630714	camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel	SCD	cd86b56e-9b4c-4aca-9740-c8793cb12055	9
630714	camphor 3 % / menthol 3 % Topical Gel	SY	cd86b56e-9b4c-4aca-9740-c8793cb12055	9
630714	camphor 3 % / menthol 3 % Topical Gel	PSN	b62f4306-8dbd-4501-8b1e-9aa78f9aee06	6
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	b62f4306-8dbd-4501-8b1e-9aa78f9aee06	6
630714	camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel	SCD	b62f4306-8dbd-4501-8b1e-9aa78f9aee06	6
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	b62f4306-8dbd-4501-8b1e-9aa78f9aee06	6
630714	camphor 3 % / menthol 3 % Topical Gel	SY	b62f4306-8dbd-4501-8b1e-9aa78f9aee06	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61577-3234-2	61577323402	907.2 g in 1 BOTTLE, PUMP (61577-3234-2)	907.2 g	2016-06-14	0000-00-00	No	No	Current
61577-3234-3	61577323403	226.8 g in 1 JAR (61577-3234-3)	226.8 g	2016-06-14	0000-00-00	No	No	Current
61577-3234-4	61577323404	113.4 g in 1 JAR (61577-3234-4)	113.4 g	2016-06-14	0000-00-00	No	No	Current
61577-3234-5	61577323405	85 g in 1 BOTTLE, PLASTIC (61577-3234-5)	85 g	2016-06-14	0000-00-00	No	No	Current
61577-3234-6	61577323406	113.4 g in 1 TUBE (61577-3234-6)	113.4 g	2016-06-14	0000-00-00	No	No	Current
61577-3234-7	61577323407	56.7 g in 1 JAR (61577-3234-7)	56.7 g	2016-06-14	0000-00-00	No	No	Current
61577-3234-8	61577323408	28.3 g in 1 PACKAGE (61577-3234-8)	28.3 g	2017-06-01	0000-00-00	Yes	No	Current
61577-3234-9	61577323409	5 g in 1 POUCH (61577-3234-9)	5 g	2016-06-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sore No More Warm Therapy Natural Pain Relieving Gel	SOMBRA COSMETICS INC.	2025-05-12	HUMAN OTC DRUG LABEL	9
Diclofenac Sodium and Menthol / Camphor Gel	V2 Pharma, LLC \| Actavis Pharma, Inc. \| SOMBRA COSMETICS INC.	2024-08-13	HUMAN PRESCRIPTION DRUG LABEL	6