Eagle

Product NDC: 43405-008
11-digit product format: 434050008
Labeler code: 43405
Product ID: 43405-008_304b364d-2847-f1a8-e063-6294a90aa948
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol Methyl Salicylate
Dosage form: OIL
Route: TOPICAL
Labeler: Borden Company (Private) Limited
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-05-14
Substance: METHYL SALICYLATE; MENTHOL
Active strength: 30; 14.5 g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Eagle
Brand name suffix: Medicated
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYL SALICYLATE	30 g/100mL
MENTHOL	14.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LAV5U5022Y	Internal UNII lookup
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
1293430	Internal RxNorm lookup
1293435	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
1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43405-008-01	EagleMedicated	1 in 1 BOX	OIL	1	8
43405-008-02	EagleMedicated	1 in 1 BOX	OIL	1	8
43405-008-03	EagleMedicated	3 mL in 1 BOTTLE, GLASS	OIL	3	8
43405-008-08	EagleMedicated	1 in 1 BOX	OIL	1	8
43405-008-08	EagleMedicated	8 mL in 1 BOTTLE, GLASS	OIL	8	8
43405-008-13	EagleMedicated	1 in 1 BOX	OIL	1	8
43405-008-24	EagleMedicated	24 mL in 1 BOTTLE, GLASS	OIL	24	8
43405-008-36	EagleMedicated	36 mL in 1 BOTTLE, GLASS	OIL	36	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]	3
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]	3
CHLOROPHYLL	INACTIVE INGREDIENT	00WNZ48OR9	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]	3
ROSE OIL	INACTIVE INGREDIENT	WUB68Y35M7	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43405-008	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]	8	Current NDC, Legacy NDC, 8 package rows	20250316_1ee49cad-84d4-42cf-aa83-c0da6f1b1b84.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 123 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Universal PAIN RELIEF	LIDOCAINE	Universal Distribution Center LLC	b132a4f2-1b1f-4e80-a183-f9add449065f	2024-10-14	Warnings	Exact identifier application number: M017
Nervex Pain Relieving	CAPSAICIN	VITA SCIENCES, LLC	a39bba22-8c54-4252-9973-052dd2aaea36	2024-10-14	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain-Relieving	LIDOCAINE	NATURAL ESSENTIALS, INC.	d07fdffd-bf7c-4950-9b2d-c06d54ef4c55	2024-10-14	Warnings	Exact identifier application number: M017
Walgreens Cooling	LIDOCAINE HYDROCHLORIDE	WALGREEN COMPANY	baffb272-436c-4ad8-e053-2a95a90a56fb	2024-10-14	Warnings	Exact identifier application number: M017
Walgreens Sunburn Relief	MENTHOL	WALGREEN COMPANY	c8967fba-6c28-494b-e053-2995a90acbba	2024-10-14	Warnings	Exact identifier application number: M017
Walgreens Sunburn Relief	LIDOCAINE	WALGREEN COMPANY	d5067903-c559-dc6d-e053-2995a90a8ee3	2024-10-14	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	EXTRA STRENGTH ITCH RELIEF	Meijer Distribution Inc	18998e1c-1254-4d0c-93f1-26652c5ca076	2024-10-14	Warnings	Exact identifier application number: M017
signature care itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Safeway	3eedcd9f-8312-4d14-a0fe-6b00a00d3e73	2024-10-13	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	H E B	34c7bcd3-203f-4630-894d-3739a1576c8d	2024-10-13	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	H E B	25ec9014-64c4-44df-9e67-9f9223ffc923	2024-10-12	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	LIDOCAINE AND MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f02fa9c0-b8af-f362-e053-2a95a90ae516	2024-10-11	Warnings	Exact identifier application number: M017
Insect Sting Relief Pad	BENZOCAINE, ALCOHOL	Hubei Changjian Medical Products Co., Ltd.	6a269982-0e25-4c09-aef1-0b398bdc5ed4	2024-10-11	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	24221805-e5c9-5785-e063-6394a90a9d2f	2024-10-10	Warnings	Exact identifier application number: M017
De La Cruz Camphor	CAMPHOR	DLC Laboratories, Inc.	62359237-de2d-4497-bfd6-36991cfc8acf	2024-10-10	Warnings	Exact identifier application number: M017
Anti Itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Meijer Distribution Inc	4f536a86-6419-4ab0-a7e8-5c37943823e2	2024-10-09	Warnings	Exact identifier application number: M017
terrasil Bruise and Pain Relief Maximum Strength	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	240b231d-a8b2-c64c-e063-6394a90a7440	2024-10-09	Warnings	Exact identifier application number: M017
Muscle Freeze Relief	MENTHOL	NATURAL ESSENTIALS, INC.	815c534b-096d-49f2-b5f2-8c885d45a5e6	2024-10-09	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	2410dc2f-9332-19fa-e063-6394a90a2835	2024-10-09	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain-Relieving	LIDOCAINE	Natural Essentials, Inc.	fc23b2e2-4abc-4119-b8bd-305b4327f1dd	2024-10-09	Warnings	Exact identifier application number: M017
KERACARE	MENTHOL 1%	Avlon Industries, Inc.	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	2024-10-09	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1293435	EAGLE BRAND Medicated 14.5 % / 30 % Topical Oil	PSN	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	8
1293430	menthol 14.5 % / methyl salicylate 30 % Topical Oil	PSN	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	8
1293435	menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]	SBD	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	8
1293430	menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil	SCD	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	8
1293435	Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical Oil	SY	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	8
1293435	Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical Oil	SY	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	8
1293430	menthol 14.5 % / methyl salicylate 30 % Topical Oil	SY	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43405-008-01	43405000801	1 BOTTLE, GLASS in 1 BOX (43405-008-01) / 24 mL in 1 BOTTLE, GLASS (43405-008-24)		2012-05-14	0000-00-00	No	No	Current
43405-008-02	43405000802	1 BOTTLE, GLASS in 1 BOX (43405-008-02) / 36 mL in 1 BOTTLE, GLASS (43405-008-36)		2012-05-14	0000-00-00	No	No	Current
43405-008-03	43405000803	3 mL in 1 BOTTLE, GLASS	3 ml					Historical
43405-008-08	43405000808	1 BOTTLE, GLASS in 1 BOX (43405-008-08) / 8 mL in 1 BOTTLE, GLASS		2022-06-27	0000-00-00	No	No	Current
43405-008-13	43405000813	1 BOTTLE, GLASS in 1 BOX (43405-008-13) / 3 mL in 1 BOTTLE, GLASS (43405-008-03)		2012-05-14	0000-00-00	No	No	Current
43405-008-24	43405000824	24 mL in 1 BOTTLE, GLASS	24 ml					Historical
43405-008-36	43405000836	36 mL in 1 BOTTLE, GLASS	36 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eagle Menthol Mthylslcylte Oil	Borden Company (Private) Limited \| Eagle Indo Pharma	2025-03-14	HUMAN OTC DRUG LABEL	8