BiOFREEZE

Manufacturer: Reckitt Benckiser LLC
Effective date: 2026-05-13
Label type: HUMAN OTC DRUG LABEL
Version: 35
Source: full-release
Hydrated at: 2026-06-01 01:57:22

Label at a glance#

ProductBIOFREEZE

Active ingredientMENTHOL, UNSPECIFIED FORM

Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

Adults and children 2 years of age and older: Rub a thin film over affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a physician wash hands after use with cool water

Storage and handling

- store at 20-25°C (68-77°F) - store in a cool dry place away from direct sunlight

Contacts and useful links#

PhoneLabel contact1-800-246-3733

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 4%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warnings:

WARNINGS SECTION

For external use only

Flammable: Keep away from excessive heat or open flame

When using this product:

OTC - WHEN USING SECTION

• Use only as directed • Avoid contact with the eyes or on mucous membranes • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if:

OTC - STOP USE SECTION

You experience pain, swelling or blistering of the skin; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days; arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breastfeeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:Rub a thin film over affected area not more than 3 to 4 times daily
Children under 2 years of age:Consult a physician
wash hands after use with cool water

Other information

STORAGE AND HANDLING SECTION

- store at 20-25°C (68-77°F) - store in a cool dry place away from direct sunlight

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

Questions or Comments:

OTC - QUESTIONS SECTION

1-800-246-3733

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY
RECOMMENDED ^®

NDC 59316-102-30

BiOFREEZE ^®
COOL THE PAIN

GEL

MENTHOL-PAIN
RELIEVING GEL

16 FL OZ (1 PT) 473 mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1111683	BIOFREEZE 4 % Topical Gel	PSN	35
415974	menthol 4 % Topical Gel	PSN	35
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	35
415974	menthol 0.04 MG/MG Topical Gel	SCD	35
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	35
1111683	Biofreeze 4 % Topical Gel	SY	35
415974	menthol 4 % Topical Gel	SY	35

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

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

BIOFREEZE
MENTHOL
.ALPHA.-TOCOPHEROL ACETATE
ALOE VERA LEAF
ARNICA MONTANA FLOWER
ARCTIUM LAPPA ROOT
FRANKINCENSE
CALENDULA OFFICINALIS FLOWER
GREEN TEA LEAF
CAMPHOR (SYNTHETIC)
GLYCERIN
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL
ISOPROPYL MYRISTATE
MELISSA OFFICINALIS LEAF
SILICON DIOXIDE
TROLAMINE
WATER
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
MENTHOL, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59316-102	59316-102-10, 59316-102-11, 59316-102-15, 59316-102-20, 59316-102-25, 59316-102-30, 59316-102-40, 59316-102-50, 59316-102-98, 59316-102-80, 59316-102-12, 59316-102-16, 59316-102-28, 59316-102-90, 59316-102-91, 59316-102-92

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
ARCTIUM LAPPA ROOT	597E9BI3Z3	IACT
FRANKINCENSE	R9XLF1R1WM	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
GLYCERIN	PDC6A3C0OX	IACT
ILEX PARAGUARIENSIS LEAF	1Q953B4O4F	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
MELISSA OFFICINALIS LEAF	50D2ZE9219	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 323 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii+route 102 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 51 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 51 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 51 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route 51 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 51 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route 51 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 51 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route 51 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
CAMPHOR (SYNTHETIC)	CAMPHOR (SYNTHETIC)	5TJD82A1ET	JELLY / NASAL	65 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CAMPHOR (SYNTHETIC)	CAMPHOR (SYNTHETIC)	5TJD82A1ET	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 51 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii+route 102 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
CAMPHOR (SYNTHETIC)	CAMPHOR (SYNTHETIC)	5TJD82A1ET	JELLY / NASAL	65 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
CAMPHOR (SYNTHETIC)	CAMPHOR (SYNTHETIC)	5TJD82A1ET	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii+route 102 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
CAMPHOR (SYNTHETIC)	CAMPHOR (SYNTHETIC)	5TJD82A1ET	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 51 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 51 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 17 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 102 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 51 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIOFREEZE	MENTHOL	Reckitt Benckiser LLC	83d5c2f2-2413-4d28-83b2-0808d0917b4d	2026-05-13	Warnings	Exact identifier ndc (package): 59316-102-25 ndc (package): 59316-102-91 ndc (package): 59316-102-15 ndc (package): 59316-102-20 ndc (package): 59316-102-92 ndc (package): 59316-102-12 ndc (package): 59316-102-90 ndc (package): 59316-102-80 ndc (package): 59316-102-50 ndc (package): 59316-102-40 ndc (package): 59316-102-98 ndc (package): 59316-102-11 ndc (package): 59316-102-28 ndc (package): 59316-102-16 ndc (package): 59316-102-30 ndc (package): 59316-102-10 ndc (product): 59316-102 ndc11 (package): 59316010216 ndc11 (package): 59316010211 ndc11 (package): 59316010230 ndc11 (package): 59316010215 ndc11 (package): 59316010240 ndc11 (package): 59316010210 ndc11 (package): 59316010212 ndc11 (package): 59316010291 ndc11 (package): 59316010228 ndc11 (package): 59316010292 ndc11 (package): 59316010225 ndc11 (package): 59316010280 ndc11 (package): 59316010290 ndc11 (package): 59316010250 ndc11 (package): 59316010298 ndc11 (package): 59316010220 spl id: 51b44481-a7ad-8a46-e063-6294a90aefda spl set id: 83d5c2f2-2413-4d28-83b2-0808d0917b4d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.