Salonpas Pain Relief

Product NDC: 46581-675
Requested package NDC: 46581-675-01
11-digit product format: 465810675
Labeler code: 46581
Product ID: 46581-675_00d9199f-7c56-4400-a4c7-b7d923666658
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol, Methyl Salicylate
Dosage form: PATCH
Route: PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler: Hisamitsu Pharmaceutical Co., Inc.
Application: NDA022029
Marketing category: NDA
Marketing start: 2018-06-01
Substance: MENTHOL; METHYL SALICYLATE
Active strength: 63; 210 mg/1; mg/1
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 · 4 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022029-001	SALONPAS	MENTHOL; METHYL SALICYLATE	3%;10%	PATCH / TOPICAL		RLD, RS	2008-02-20
N022029-002	SALONPAS	MENTHOL; METHYL SALICYLATE	3%;10%	PATCH / TOPICAL		RLD, RS	2012-11-05

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022029-001	9233184	2027-08-01	Drug product	2016-02-11
N022029-001	8809615	2030-01-03	Drug product	2014-08-19
N022029-002	9233184	2027-08-01	Drug product	2016-02-11
N022029-002	8809615	2030-01-03	Drug product	2014-08-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022029-001	SALONPAS	3%;10%	PATCH / TOPICAL	RLD, RS	2008-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022029-002	SALONPAS	3%;10%	PATCH / TOPICAL	RLD	2012-11-05	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022029-001	9233184	2027-08-01	Drug product	2016-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022029-001	8809615	2030-01-03	Drug product	2014-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022029-002	9233184	2027-08-01	Drug product	2016-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022029-002	8809615	2030-01-03	Drug product	2014-08-19	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Salonpas Pain Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	63 mg/1
METHYL SALICYLATE	210 mg/1

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
LAV5U5022Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
853146	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
acd7ba91-221a-485a-ad1f-dd41ed155656	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
46581-675-01	2025-03-13	acd7ba91-221a-485a-ad1f-dd41ed155656
46581-675-09	2025-03-13	acd7ba91-221a-485a-ad1f-dd41ed155656
46581-675-99	2025-03-13	acd7ba91-221a-485a-ad1f-dd41ed155656
46581-675-01	2025-01-30	acd7ba91-221a-485a-ad1f-dd41ed155656
46581-675-09	2025-01-30	acd7ba91-221a-485a-ad1f-dd41ed155656
46581-675-99	2025-01-30	acd7ba91-221a-485a-ad1f-dd41ed155656

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46581-675-01	Salonpas Pain Relief	1 in 1 POUCH	PATCH	1	6
46581-675-09	Salonpas Pain Relief	3 in 1 POUCH	PATCH	3	6
46581-675-09	Salonpas Pain Relief	3 in 1 BOX	PATCH	3	6
46581-675-99	Salonpas Pain Relief	1 in 1 POUCH	PATCH	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46581-675-01	EA - Each	46581-675	47979452-bb65-4b1f-a851-aeeb9ca5e2e8	1	2021-01-08
46581-675-09	EA - Each	46581-675	6f894a4b-a8f8-4634-b824-59920d9ece40	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46581-675	SALONPAS PAIN RELIEF (MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]	6	Current NDC, Legacy NDC, 4 package rows	20250316_acd7ba91-221a-485a-ad1f-dd41ed155656.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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NUMBING	MENTHOL	FlexiGo Inc	4ce416dd-2430-4648-e063-6294a90ab199	2026-03-13	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029
Salonpas Pain Relief	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	acd7ba91-221a-485a-ad1f-dd41ed155656	2025-03-14	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029 ndc (package): 46581-675-01 ndc (product): 46581-675 ndc11 (package): 46581067501
Salonpas Pain Relief	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2	2025-03-14	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029
Salonpas Arthritis Pain	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	2e88c933-89e6-4a48-be7a-dc6a36e5c8f8	2025-03-14	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029
Salonpas Arthritis Pain	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	a6518167-fe32-43b2-b736-ba01ac69c12d	2024-12-13	Warnings	Exact identifier application applno (NDA): 022029 application number: NDA022029

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
853146	menthol 3 % / methyl salicylate 10 % Medicated Patch	PSN	acd7ba91-221a-485a-ad1f-dd41ed155656	6
853146	menthol 0.03 MG/MG / methyl salicylate 0.1 MG/MG Medicated Patch	SCD	acd7ba91-221a-485a-ad1f-dd41ed155656	6
853146	menthol 3 % / methyl salicylate 10 % Medicated Patch	SY	acd7ba91-221a-485a-ad1f-dd41ed155656	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46581-675-01	46581067501	1 PATCH in 1 POUCH (46581-675-01)	1 patch	2020-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Salonpas Pain Relief - Hisamitsu Pharmaceutical Co., Inc.	Hisamitsu Pharmaceutical Co., Inc.	2025-03-14	HUMAN OTC DRUG LABEL	6