BIO-ICE

Product NDC: 50130-316
11-digit product format: 501300316
Labeler code: 50130
Product ID: 50130-316_463d9205-8ccc-8c5c-e063-6394a90a47c5
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, CAMPHOR
Dosage form: GEL
Route: TOPICAL
Labeler: Electrostim Medical Services Inc. d/b/a EMSI
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-01-01
Substance: MENTHOL; CAMPHOR (SYNTHETIC)
Active strength: 5.4; .48 g/100mL; g/100mL
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 · 8 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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50130-316-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50130-316-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50130-316-11	`bd6a592717d7…`	`303034d00443…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50130-316-11	`e2bbac7714bc…`	`27bdfed8d636…`

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: BIO-ICE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	5.4 g/100mL
CAMPHOR (SYNTHETIC)	.48 g/100mL

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
1372902	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
1bfd1468-9139-43b1-9709-d47b63d17cfb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-10-20	BIO-ICE
2022-01-28	BIO-ICE
2020-12-31	BIO-ICE
2020-09-27	BIO-ICE
2020-09-25	BIO-ICE
2020-07-22	BIO-ICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50130-316-11	BIO-ICE	88.8 mL in 1 BOTTLE	GEL	88.8		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
BOSWELLIA SERRATA RESIN OIL	INACTIVE INGREDIENT	5T1XCE6K8K	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
CAMPHOR OIL	INACTIVE INGREDIENT	75IZZ8Y727	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
UNCARIA TOMENTOSA LEAF	INACTIVE INGREDIENT	487U8M3D2P	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50130-316	BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]	7	Current NDC, Legacy NDC, 1 package rows	20241213_1bfd1468-9139-43b1-9709-d47b63d17cfb.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 2 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ActivICE	MENTHOL	Medline Industries, LP	834adeb9-38ad-0cfe-e053-2991aa0af82f	2026-09-01	Warnings	Exact identifier application number: M017
La Vaquita New Extra	METHYL SALICYLATE, MENTHOL	Delon Laboratories (1990) Ltd	3097a01b-cee5-492f-b65a-63992fb28e3a	2026-09-01	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort Hydrocortisone 1% Cream	HYDROCORTISONE	Rida LLC	0d2c0c2c-370f-4adb-b0ea-1e218c927f8b	2026-09-01	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	HyVee Inc	53157137-b980-45d2-aa10-8c111c0ec2f4	2026-08-31	Warnings	Exact identifier application number: M017
EAYONYUMT NECK PAIN RELIEF	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a450e68-07a7-a4bb-e063-6294a90a97c9	2026-08-30	Warnings	Exact identifier application number: M017
EAYONYUM BACK PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a458280-4f9c-5af6-e063-6394a90acb2e	2026-08-30	Warnings	Exact identifier application number: M017
EAYONYUM KNEE PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a45d19f-c753-71eb-e063-6294a90a4805	2026-08-30	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin	HYDROCORTISONE	AmerisourceBergen	c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495	2026-08-30	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	HAWAII REPACK, INC.	31ed3d82-ba12-46b2-b0ec-7e5e019efc10	2026-08-28	Warnings	Exact identifier application number: M017
4% Lidocaine Patches	4% LIDOCAINE PATCHES	Shenzhen Chaoxiji Technology Co.,Ltd.	5a177987-7c05-f07f-e063-6394a90aa9ba	2026-08-28	Warnings	Exact identifier application number: M017
Relieved Pro Wrap	4% LIDOCAINE PATCH	Transfer Technology	5a1c6ebf-ad3f-c47b-e063-6294a90aa19a	2026-08-28	Warnings	Exact identifier application number: M017
Sinsinpas Arex Pain Relieving Patch, Medium	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	46453ef2-512b-4852-e063-6394a90a8912	2026-08-28	Warnings	Exact identifier application number: M017
Sinsinpas arex patch large	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	47c242da-56cd-bea1-e063-6394a90a41de	2026-08-28	Warnings	Exact identifier application number: M017
4% Lidocaine Patches	4% LIDOCAINE PATCHES	Shenzhen Chaoxiji Technology Co.,Ltd.	5a16c6aa-3ab0-3e46-e063-6294a90a6d8f	2026-08-27	Warnings	Exact identifier application number: M017
Lidocaine Patch 4%	LIDOCAINE 4%	Global America Group LLC	1eec782d-0e56-43d2-b842-da0ae47c5dc9	2026-08-26	Warnings	Exact identifier application number: M017
Careland Lidocaine Plus Menthol Pain Relieving	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd	0f928b5b-60f5-4a45-a409-c601eb330487	2026-08-26	Warnings	Exact identifier application number: M017
PARCHE CALIENTE	CAPSAICINA AND MENTOL	DW SUPPORT LLC	59f2708e-295a-ccb3-e063-6394a90ad395	2026-08-26	Warnings	Exact identifier application number: M017
CVS Pain Relief	LIDOCAINE	CVS Pharmacy	4ecbc263-e0d4-18d5-e063-6294a90a72e9	2026-08-26	Warnings	Exact identifier application number: M017
CVS Pain Relief Lidocaine XL	LIDOCAINE	CVS Pharmacy	4aa286e3-e274-8095-e063-6394a90ae871	2026-08-26	Warnings	Exact identifier application number: M017
TERAPIA DE DIA Y NOCHE	PAIN RELIEVING PATCH	DW SUPPORT LLC	59f44135-865b-9d7d-e063-6294a90a9dd9	2026-08-26	Warnings	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
1372902	camphor 0.48 % / menthol 5.4 % Topical Gel	PSN	1bfd1468-9139-43b1-9709-d47b63d17cfb	8
1372902	camphor 0.0048 MG/MG / menthol 0.054 MG/MG Topical Gel	SCD	1bfd1468-9139-43b1-9709-d47b63d17cfb	8
1372902	camphor 0.48 % / menthol 5.4 % Topical Gel	SY	1bfd1468-9139-43b1-9709-d47b63d17cfb	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50130-316-11	50130031611	88.8 mL in 1 BOTTLE (50130-316-11)	88.8 ml	2013-01-01	0000-00-00	No	No	Current