NUMBING

Product NDC: 85524-2605
11-digit product format: 855242605
Labeler code: 85524
Product ID: 85524-2605_4ce416dd-2431-4648-e063-6294a90ab199
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: FlexiGo Inc
Application: NDA022029
Marketing category: NDA
Marketing start: 2026-03-28
Substance: MENTHOL; METHYL SALICYLATE
Active strength: 3; 10 g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: NUMBING
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	3 g/100mL
METHYL SALICYLATE	10 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
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
1486874	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
4ce416dd-2430-4648-e063-6294a90ab199	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85524-2605-1	NUMBING	60 mL in 1 BOTTLE	CREAM	60		1
85524-2605-2	NUMBING	1 in 1 BOX	CREAM	1		1

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 ndc (product): 85524-2605
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
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
1486874	menthol 3 % / methyl salicylate 10 % Topical Cream	PSN	4ce416dd-2430-4648-e063-6294a90ab199	1
1486874	menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical Cream	SCD	4ce416dd-2430-4648-e063-6294a90ab199	1
1486874	menthol 3 % / methyl salicylate 10 % Topical Cream	SY	4ce416dd-2430-4648-e063-6294a90ab199	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85524-2605-1	85524260501	60 mL in 1 BOTTLE	60 ml				Historical
85524-2605-2	85524260502	1 BOTTLE in 1 BOX (85524-2605-2) / 60 mL in 1 BOTTLE (85524-2605-1)	1 bottle	2026-03-28	No	No	Current