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 10 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gaayou Numbing	DIBUCAINE HYDROCHLORIDE 0.5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4c290118-7880-2a98-e063-6294a90a4c03	2026-07-21	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving Cold Gel	CAMPHOR, MENTHOL	Active and Innovative	572792bb-2819-36c3-e063-6394a90aa504	2026-07-21	Warnings	Exact identifier application number: M017
SYLVIRENE NUMBING	LIDOCAINE 4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a36edc5-5a89-afb5-e063-6294a90a02dd	2026-07-21	Warnings	Exact identifier application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	LIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	Jiangxi Yudexi Pharmaceutical Co., LTD	4a45c1cb-c5ab-d872-e063-6394a90aab5d	2026-07-21	Warnings	Exact identifier application number: M017
SERYNTH Muscle Comfort	ARNICA MONTANA HPUS 7% MUSCLE COMFORT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c10cd-f0c4-8731-e063-6394a90a10a5	2026-07-21	Warnings	Exact identifier application number: M017
DERMFREE MEDICATED LIP	CAMPHOR 2.0% MEDICATED LIP	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d62fb-8dfa-404a-e063-6294a90a385d	2026-07-21	Warnings	Exact identifier application number: M017
NATUHEAL RELIEF Cream FOR ECZEMA	HYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMA	Jiangxi Yudexi Pharmaceutical Co., LTD	4c92fed1-a8b4-bda8-e063-6394a90a8a33	2026-07-20	Warnings	Exact identifier application number: M017
REDCOOL Arnica Bruise	ARNICA MONTANA HPUS 7% ARNICA BRUISE	Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.	49911392-e55e-1a6b-e063-6394a90a9af0	2026-07-20	Warnings	Exact identifier application number: M017
Vamy HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	499197aa-f872-3abf-e063-6294a90aeda2	2026-07-20	Warnings	Exact identifier application number: M017
Subleef NUMBING	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a201a6b-adde-c0a8-e063-6394a90a8285	2026-07-20	Warnings	Exact identifier application number: M017
PUVIDA NUMBING	MENTHOL 5% (W/W) NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4de4e317-2f4f-e5d6-e063-6394a90a0611	2026-07-20	Warnings	Exact identifier application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	8b607c03-a98f-445a-a69e-7625a76ac44b	2026-07-20	Warnings	Exact identifier application number: M017
Yodo Salil	OINTMENT	Laboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.	56812625-7eab-6a25-e063-6294a90a23fe	2026-07-20	Warnings	Exact identifier application number: M017
VBBV Numbing	LIDOCAINE	Jiashen International Trade Limited	5716c36b-6e97-c294-e063-6394a90aaf5c	2026-07-20	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	Premier Brands of America Inc.	560c29cc-2453-5d14-e063-6394a90a844f	2026-07-17	Warnings	Exact identifier application number: M017
4% Lidocaine Pain Relief Patch	LIDOCAINE 4%	Guangxi Keyun E-commerce Co., Ltd.	4981e9c3-2a19-aed8-e063-6294a90af216	2026-07-17	Warnings	Exact identifier application number: M017
endurance wipe	BENZOCAINE	Absorption Pharmaceuticals, LLC	303db1de-94fc-4543-e063-6294a90a01b9	2026-07-17	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare pain relieving gel Extra Strength	CAMPHOR, MENTHOL	Active and Innovative Inc.	56d30c33-ef5a-c63d-e063-6294a90acd29	2026-07-17	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Gel Alpine Fresh Scent	MENTHOL	Carlin Consumer Health LLC	56d3ca3d-21e1-a40a-e063-6294a90a9ff4	2026-07-17	Warnings	Exact identifier application number: M017
DRAVYNOR TOPICAL ANALGESIC HEAT Patch	MENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b83ee8-8d86-9436-e063-6294a90a0c25	2026-07-16	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