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 25 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LidoTape	LIDOCAINE 4%	V2 Pharma LLC	ed18b4f7-6a2c-4dce-9b53-e485569093c5	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	4f112ab2-b67a-a3e2-e063-6394a90acb60	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Pain Relief	MENTHOL	Veridian Healthcare	4f11aa1e-de53-a3b0-e063-6294a90a2fe4	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare 2X Medicated Pain Relief	LIDOCAINE, MENTHOL	Veridian Healthcare	4f11fca1-1949-ab8e-e063-6394a90ac627	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Medicated Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Veridian Healthcare	4f125062-af89-40d3-e063-6394a90a27ef	2026-04-09	Warnings	Exact identifier application number: M017
DRMITSUI ECZEMA RELIEF	HYDROCORTISONE 1% ECZEMA RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4eee7637-3a28-e0bd-e063-6294a90ae1a4	2026-04-08	Warnings	Exact identifier application number: M017
SINSIN MULPAS	L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR	Sinsin Pharmaceutical Co., Ltd.	47c077c2-6e34-8e7a-e063-6294a90a21b5	2026-04-08	Warnings	Exact identifier application number: M017
Yi Tiao Gen Pain Patch	PAIN PATCH	Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory	4828fe70-f6f8-45e4-9c9a-a9e486dc65e5	2026-04-07	Warnings	Exact identifier application number: M017
Dermatool Nerve Care	LIDOCAINE HCL, MENTHOL	Papalo Group, LLC	4ee40c96-9350-4c68-e063-6294a90ac812	2026-04-07	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	CVS Pharmacy, Inc.	42b3c341-f422-b2b4-e063-6294a90a47b2	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Pain Relieving Topical Analgesic	MENTHOL	Phoenix Bioperformance Products LLC	bb4c9e73-e62d-4b8c-a16c-b90db1a8b2a7	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Anti-Inflammatory and Pain Relief	MENTHOL	Phoenix Bioperformance Products LLC	39a6d26b-b5f4-45d7-a9b5-6edbf42d7500	2026-04-06	Warnings	Exact identifier application number: M017
Dr. Blue PainZaway Pain Relieving Roll-On	MENTHOL	Indiana Botanic Gardens	4ecc8241-5a87-2f45-e063-6294a90aa30a	2026-04-06	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	CVS Pharmacy, Inc.	d7f52394-5cc1-48a6-ae89-9fc63b515758	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M017
Pain-Relieving Patch	CAMPHOR, MENTHOL, METHYL SALICYLATE	CVS Pharmacy	4ecf4a6e-5c0f-7943-e063-6394a90a81cc	2026-04-06	Warnings	Exact identifier application number: M017
RAPID RELIEF	0.025% CAPSAICIN PAIN PATCH	RAPID AID VIET NAM COMPANY LIMITED	4edbaa1a-6e44-4865-e063-6394a90a8cc3	2026-04-06	Warnings	Exact identifier application number: M017
Capsaicin 0.1% Cream	CAPSAICIN 0.1%	Puretek Corporation	4e83441b-cb6a-beb0-e063-6394a90a1b54	2026-04-03	Warnings	Exact identifier application number: M017
NeroCare Capsaicin Neuropathy Relief Cream	CAPSAICIN	Guangzhou Tata Biotechnology Co., Ltd.	4e89b7eb-0d84-dc57-e063-6394a90a7dd9	2026-04-03	Warnings	Exact identifier application number: M017
TheraCare Pain Relief Patch	LIDOCAINE 4%	Veridian Healthcare	4e91da65-8191-6261-e063-6394a90a6bd5	2026-04-03	Warnings	Exact identifier application number: M017
HealthWise Roll-On	LIDOCAINE, MENTHOL	Veridian Healthcare	4e9306b5-949e-f7a9-e063-6394a90ae13a	2026-04-03	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