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 78 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine-Pain-Relief-Patch	LIDOCAINE-PAIN-RELIEF-PATCH	Henan Enokon Medical Instrument Co., Ltd.	3ecfa867-50f6-d98a-e063-6394a90aefa0	2025-09-14	Warnings	Exact identifier application number: M017
Meijer Hydrocortsione Cream	HYDROCORTSIONE CREAM 1%	Meijer Distribution Inc.	1cbddb7e-f2e3-0951-e063-6394a90a3d37	2025-09-12	Warnings	Exact identifier application number: M017
JO Prolonger with Benzocaine	BENZOCAINE	CC Wellness LLC	d955f612-1267-f1be-e053-2995a90a5345	2025-09-12	Warnings	Exact identifier application number: M017
JO for Him Prolonger with Lidocaine	LIDOCAINE	CC Wellness LLC	b12dc6a3-142d-3219-e053-2995a90aead0	2025-09-12	Warnings	Exact identifier application number: M017
Walgreens Medicated Foot Powder	MENTHOL	Davion, Inc	58e1e7f7-6284-411f-9765-0e63eabca0f3	2025-09-12	Warnings	Exact identifier application number: M017
PAIN RELIEF PATCHES	LIDOCAINE	Amerisource Bergen	614f1e56-891f-4620-be10-0c075a1dbc3f	2025-09-11	Warnings	Exact identifier application number: M017
Industrial Itch and Pain Relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	R & R Lotion, Inc	236415fc-f923-4a82-b54a-ecaf666dd2e0	2025-09-11	Warnings	Exact identifier application number: M017
Eco Lips Menthol Medicated Lip Balm	MENTHOL	Eco Lips, Inc.	fc4c25d6-6109-dfd8-e053-6394a90a4e91	2025-09-10	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Encube Ethicals, Inc.	d6f5c0df-6262-4704-bb24-430f66bb2ca8	2025-09-09	Warnings	Exact identifier application number: M017
Blue-Emu Lidocaine Pain Relief Cream	LIDOCAINE CREAM 4%	Kingsway Pharmaceuticals dba NFI, LLC	592811f2-e21c-6a58-e053-2991aa0a69a9	2025-09-09	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	282ed5ef-8c2a-4092-9d99-1a7eee7a39e3	2025-09-09	Warnings	Exact identifier application number: M017
LubeLife Climax Control Delay	BENZOCAINE	CC Wellness LLC	e1a98e6d-0c24-75b8-e053-2a95a90ad136	2025-09-09	Warnings	Exact identifier application number: M017
Blue-Emu Maximum Pain Relief	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	c863351a-951b-4f7c-a9c0-4289d702054a	2025-09-09	Warnings	Exact identifier application number: M017
Tiger Balm Neck and Shoulder Rub	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	02a65b25-78b2-4e29-9484-40e2228fb384	2025-09-09	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	e90df2e5-2ef4-47dd-bd74-be9cea6d9d85	2025-09-08	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	2025-09-08	Warnings	Exact identifier application number: M017
SupreH Arnica Bruise Cream	SUPREH ARNICA REMEDY PLUS BRUISE CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3e41fc0e-54c3-2622-e063-6294a90a13c9	2025-09-07	Warnings	Exact identifier application number: M017
Menthol	MENTHOL	FlexiGo Inc	3607c326-6db0-a2cd-e063-6394a90a9eb6	2025-09-06	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYOTHERAPY MENTHOL Cream	PAIN RELIEF CRYOTHERAPY MENTHOL CREAM	Shenzhen Sam Technology Co., Ltd.	3e08cc87-2385-0838-e063-6394a90abf9b	2025-09-05	Warnings	Exact identifier application number: M017
TIDL CLINICAL CRYOTHERAPY MENTHOL Cream	CLINICAL CRYOTHERAPY MENTHOL CREAM	Shenzhen Sam Technology Co., Ltd.	3e090b98-1db7-4174-e063-6394a90aa539	2025-09-05	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