BIOFREEZE

Product NDC: 59316-102
11-digit product format: 593160102
Labeler code: 59316
Product ID: 59316-102_51b44481-a7ad-8a46-e063-6294a90aefda
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Reckitt Benckiser LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-01-03
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 40 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	59316-102	59316-102-15	D	Discontinued by firm	2026-10-21
excluded package	package	59316-102	59316-102-16	D	Discontinued by firm	2026-10-21
excluded package	package	59316-102	59316-102-25	D	Discontinued by firm	2026-10-21
excluded package	package	59316-102	59316-102-91	D	Discontinued by firm	2026-10-21
excluded package	package	59316-102	59316-102-92	D	Discontinued by firm	2026-10-21

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	59316-102-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59316-102-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59316-102-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	59316-102-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59316-102-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59316-102-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	59316-102-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59316-102-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59316-102-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	59316-102-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59316-102-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59316-102-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	59316-102-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59316-102-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59316-102-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	59316-102-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59316-102-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59316-102-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	59316-102-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59316-102-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59316-102-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	59316-102-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59316-102-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59316-102-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	59316-102-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59316-102-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59316-102-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	59316-102-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59316-102-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59316-102-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	59316-102-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59316-102-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59316-102-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	59316-102-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59316-102-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59316-102-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: BIOFREEZE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
415974	Internal RxNorm lookup
1111683	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
83d5c2f2-2413-4d28-83b2-0808d0917b4d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-102-10	BIOFREEZE	5 mL in 1 BOTTLE	GEL	5	35
59316-102-11	BIOFREEZE	3 mL in 1 BOTTLE	GEL	3	35
59316-102-12	BIOFREEZE	89 mL in 1 BOTTLE	GEL	89	35
59316-102-15	BIOFREEZE	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89	35
59316-102-16	BIOFREEZE	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89	35
59316-102-20	BIOFREEZE	118 mL in 1 BOTTLE	GEL	118	35
59316-102-25	BIOFREEZE	118 mL in 1 BOTTLE, WITH APPLICATOR	GEL	118	35
59316-102-28	BIOFREEZE	237 mL in 1 BOTTLE	GEL	237	35
59316-102-30	BIOFREEZE	473 mL in 1 BOTTLE	GEL	473	35
59316-102-40	BIOFREEZE	946 mL in 1 BOTTLE	GEL	946	35
59316-102-50	BIOFREEZE	3785 mL in 1 CONTAINER	GEL	3785	35
59316-102-80	BIOFREEZE	44 mL in 1 TUBE	GEL	44	35
59316-102-90	BIOFREEZE	100 in 1 CARTON	GEL	100	35
59316-102-91	BIOFREEZE	10 in 1 CARTON	GEL	10	35
59316-102-92	BIOFREEZE	16 in 1 CARTON	GEL	16	35
59316-102-98	BIOFREEZE	30 mL in 1 BOTTLE	GEL	30	35
59316-102-80	Biofreeze	44 mL in 1 TUBE	GEL	44	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-102-12	ML - Milliliter	59316-102	8c11b8a5-4f02-41bf-88b6-e4af8c4214f8	1	2018-09-05
59316-102-20	ML - Milliliter	59316-102	63342204-7fd4-4732-9ec3-4df580a6e6ce	1	2015-06-09
59316-102-28	ML - Milliliter	59316-102	e8471990-bf89-42b8-8a43-721055ce7645	1	2018-09-05
59316-102-30	ML - Milliliter	59316-102	8537e275-8662-4f2c-ae52-44981681af99	1	2024-08-12
59316-102-40	ML - Milliliter	59316-102	030b1aca-eae8-43da-9839-6522c8c985ac	1	2024-08-12
59316-102-50	ML - Milliliter	59316-102	35b2fa59-5fb2-4779-a89d-b84cda167825	1	2024-08-12
59316-102-80	ML - Milliliter	59316-102	39ef3edc-90e7-4701-bbcc-add710ddea6d	1	2024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
FRANKINCENSE	INACTIVE INGREDIENT	R9XLF1R1WM	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
MELISSA OFFICINALIS LEAF	INACTIVE INGREDIENT	50D2ZE9219	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-102	BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC]	34	Current NDC, Legacy NDC, 16 package rows	20231114_83d5c2f2-2413-4d28-83b2-0808d0917b4d.zip
59316-102	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20181108_f0c4d165-a242-4fb5-b2de-d64a825a29e9.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 43 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sarna	PRAMOXINE HYDROCHLORIDE	Crown Laboratories	19b0ce1b-e147-01a1-e063-6394a90af808	2026-01-12	Warnings	Exact identifier application number: M017
Sarna	PRAMOXINE HYDROCHLORIDE, MENTHOL	Crown Laboratories, Inc	19c41e75-a654-90cf-e063-6394a90a7e97	2026-01-12	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	HY-VEE, INC	48350b54-8d9a-48c4-e063-6394a90ac040	2026-01-12	Warnings	Exact identifier application number: M017
LidoPlus Pain Relief	LIDOCAINE HYDROCHLORIDE	Centura Pharmaceuticals, Inc	07bacc6c-60a6-4297-8663-904a22bdc040	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f1efb51c-5217-4cb2-e053-2a95a90a7f95	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f2277e27-868b-57ef-e053-2a95a90abf28	2026-01-12	Warnings	Exact identifier application number: M017
BLT 3	TETRACAINE	CENTURA PHARMACEUTICALS INC	401a0d22-1181-02ac-e054-00144ff88e88	2026-01-12	Warnings	Exact identifier application number: M017
Sting Relief Prep Pad	BENZOCAINE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	0c901f64-6890-45c0-9ca7-ee9de87903c4	2026-01-12	Warnings	Exact identifier application number: M017
Goodsense Oral Pain Relief	BENZOCAINE	Geiss, Destin and Dunn, Inc.	eb461b70-d10f-4e11-8374-e43713f3504d	2026-01-12	Warnings	Exact identifier application number: M017
Extra Strength Balm	CAPSICUM AND MENTHOL	Saje Natural Business Inc	f516e416-446b-8f21-e053-2a95a90afd88	2026-01-12	Warnings	Exact identifier application number: M017
Pain Release	MENTHOL	Saje Natural Business Inc.	3df0e56a-7651-42dc-8ed8-f68836a63c61	2026-01-12	Warnings	Exact identifier application number: M017
Trauma Less	MENTHOL	Saje Natural Business Inc.	650cba4c-6aba-48c3-9c41-841f19905548	2026-01-12	Warnings	Exact identifier application number: M017
Mamisan	LIDOCAINE HYDROCHLORIDE, MENTHOL	Miramar Cosmetics, Inc DBA Miramar Lab	4402e900-c6e9-4f32-8cc4-c84014384a9f	2026-01-12	Warnings	Exact identifier application number: M017
Curist Lidocaine Patch	LIDOCAINE 4% PATCH	Little Pharma, Inc.	1a8fe44e-7a21-c2ab-e063-6394a90a6100	2026-01-11	Warnings	Exact identifier application number: M017
DG Health Pain Relieving	LIDOCAINE HCL	DOLGENCORP, LLC	923aeb4c-049f-4ecc-a77e-9ffa0e236d4e	2026-01-11	Warnings	Exact identifier application number: M017
Campho-Phenique Antiseptic	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare	46b84e0b-78a9-4cde-9f90-e165b5419162	2026-01-09	Warnings	Exact identifier application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On	MENTHOL	Inspec Solutions	12ff9b9a-73e5-ce31-e063-6294a90aeaf8	2026-01-09	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bb0278c9-eaff-d435-e053-2995a90a202a	2026-01-09	Warnings	Exact identifier application number: M017
Lidocaine HCI	LIDOCAINE HCI	Trifluent Pharma, LLC	47f7f06b-720e-eeec-e063-6294a90ae823	2026-01-09	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Bellus Medical, LLC	60cb89f6-e326-0773-e053-2a91aa0a33dd	2026-01-09	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111683	BIOFREEZE 4 % Topical Gel	PSN	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
415974	menthol 4 % Topical Gel	PSN	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
415974	menthol 0.04 MG/MG Topical Gel	SCD	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
1111683	Biofreeze 4 % Topical Gel	SY	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
415974	menthol 4 % Topical Gel	SY	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
1111683	BIOFREEZE 4 % Topical Gel	PSN	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
415974	menthol 4 % Topical Gel	PSN	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
415974	menthol 0.04 MG/MG Topical Gel	SCD	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
1111683	Biofreeze 4 % Topical Gel	SY	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
415974	menthol 4 % Topical Gel	SY	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-102-10	59316010210	5 mL in 1 BOTTLE (59316-102-10)	5 ml	2012-01-03	0000-00-00	No	No	Current
59316-102-11	59316010211	3 mL in 1 BOTTLE (59316-102-11)	3 ml	2012-01-03	0000-00-00	No	No	Current
59316-102-12	59316010212	89 mL in 1 BOTTLE (59316-102-12)	89 ml	2016-09-19	0000-00-00	No	No	Current
59316-102-15	59316010215	89 mL in 1 BOTTLE, WITH APPLICATOR	89 ml					Historical
59316-102-16	59316010216	89 mL in 1 BOTTLE, WITH APPLICATOR	89 ml					Historical
59316-102-20	59316010220	118 mL in 1 BOTTLE (59316-102-20)	118 ml	2012-01-03	0000-00-00	No	No	Current
59316-102-25	59316010225	118 mL in 1 BOTTLE, WITH APPLICATOR (59316-102-25)	118 ml	2012-01-03	2021-12-31	No	No	Current
59316-102-28	59316010228	237 mL in 1 BOTTLE (59316-102-28)	237 ml	2016-09-19	0000-00-00	No	No	Current
59316-102-30	59316010230	473 mL in 1 BOTTLE (59316-102-30)	473 ml	2012-01-03	0000-00-00	No	No	Current
59316-102-40	59316010240	946 mL in 1 BOTTLE (59316-102-40)	946 ml	2012-01-03	0000-00-00	No	No	Current
59316-102-50	59316010250	3785 mL in 1 CONTAINER (59316-102-50)	3785 ml	2012-01-03	0000-00-00	No	No	Current
59316-102-80	59316010280	44 mL in 1 TUBE (59316-102-80)	44 ml	2018-11-02	0000-00-00	No	No	Current
59316-102-90	59316010290	100 BOTTLE in 1 CARTON (59316-102-90) / 5 mL in 1 BOTTLE (59316-102-10)	100 bottle	2012-01-03	0000-00-00	No	No	Current
59316-102-91	59316010291	10 BOTTLE in 1 CARTON (59316-102-91) > 3 mL in 1 BOTTLE (59316-102-11)	10 bottle	2012-01-03	0000-00-00	No	No	Current
59316-102-92	59316010292	16 BOTTLE in 1 CARTON (59316-102-92) > 3 mL in 1 BOTTLE (59316-102-11)	16 bottle	2012-01-03	0000-00-00	No	No	Current
59316-102-98	59316010298	30 mL in 1 BOTTLE (59316-102-98)	30 ml	2012-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BiOFREEZE ®	Reckitt Benckiser LLC	2026-05-13	HUMAN OTC DRUG LABEL	35
Biofreeze Gel	Performance Health LLC	2019-05-14	HUMAN OTC DRUG LABEL	3
Biofreeze Gel	Performance Health, LLC	2018-11-07	HUMAN OTC DRUG LABEL	1