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 14 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Roll Pain Away	CAPSAICIN	PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA	547e647b-0205-221c-e063-6294a90a757c	2026-06-17	Warnings	Exact identifier application number: M017
Roll Pain Away Lemongrass	CAPSAICIN	PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA	547ef5c0-bc31-d83e-e063-6394a90abfa6	2026-06-17	Warnings	Exact identifier application number: M017
Roll Pain Away Lavender	CAPSAICIN	PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA	547ef2d9-f5c7-9de1-e063-6394a90a218b	2026-06-17	Warnings	Exact identifier application number: M017
Velloryn EXTRA STRENGTH NEUROPATHY	VELLORYN EXTRA STRENGTH NEUROPATHY	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	547f755f-c65c-37ef-e063-6394a90aa220	2026-06-17	Warnings	Exact identifier application number: M017
Neoteric Diabetic Skin Care 4 oz.	DIMETHICONE	RNA PHARMA LLC	536f4e79-201b-7100-e063-6394a90a4f82	2026-06-16	Warnings	Exact identifier application number: M017
Medi First Extra Strength Itch Relief	DIPHENHYDRAMINE, ZINC ACETATE	Unifirst First Aid Corporation	54614e5b-8c72-d308-e063-6294a90a405d	2026-06-16	Warnings	Exact identifier application number: M017
Blue Ice Analgesic	MENTHOL	Delon Laboratories (1990) Ltd	184ed488-6e62-40c6-bb71-1d523280fd6b	2026-06-16	Warnings	Exact identifier application number: M017
Medi-First Hydrocortisone 1 % Anti-Itch Cream	HYDROCORTISONE	Unifirst First Aid Corporation	49f04e5d-746d-cbe9-e063-6294a90a7e88	2026-06-16	Warnings	Exact identifier application number: M017
Lidozall Pro	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	ecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff	2026-06-16	Warnings	Exact identifier application number: M017
Tiger Balm Pain Relieving Cool	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	41590ba1-32bb-4352-97ba-d6a3cc9d0546	2026-06-15	Warnings	Exact identifier application number: M017
HIGH POTENCY PAIN RELIEF	CAPSAICIN	Xiamen Weisiqi Technology Co., Ltd.	543949a4-86ed-3734-e063-6394a90a24f2	2026-06-14	Warnings	Exact identifier application number: M017
Natucure HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	49e402ed-d314-e896-e063-6294a90a826b	2026-06-14	Warnings	Exact identifier application number: M017
Nieapf NUMBING	LIDOCAINE 4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49e7534f-bccf-4ef4-e063-6294a90aeb7f	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ NUMBING	HEALMUSZ NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49976ff7-49a4-e4ed-e063-6294a90a3f78	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ HEMORRHOID FISSURE	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID FISSURE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a342ac0-6a8d-3408-e063-6394a90a9a10	2026-06-14	Warnings	Exact identifier application number: M017
BOTASUN QUIT SMOKING Nicotine	NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE	Jiangxi Yudexi Pharmaceutical Co., LTD	4fa00db9-def5-dcfa-e063-6394a90ac8c2	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4cbb7df5-5771-ce4b-e063-6294a90aab80	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ ECZEMA	HYDROCORTISONE 1% ECZEMA	Jiangxi Yudexi Pharmaceutical Co., LTD	511e54e0-2abe-fb76-e063-6294a90ada68	2026-06-14	Warnings	Exact identifier application number: M017
Hydrocortisone 1% Anti-ItchCream	HYDROCORTISONE	Acme United Corporation	5425fc2b-4f25-3e64-e063-6394a90aff49	2026-06-13	Warnings	Exact identifier application number: M017
Icy Hot Pain Relieving Balm	MENTHOL AND METHYL SALICYLATE	Chattem, Inc.	40c8c02f-fa5f-4e80-81a0-48271fa6f94b	2026-06-12	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