Instaflex Extra Strength Pain Relief Cream

Product NDC: 70015-660
11-digit product format: 700150660
Labeler code: 70015
Product ID: 70015-660_5190500c-53c7-a68a-e063-6394a90a52a9
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol, Methyl Salicylate
Dosage form: CREAM
Route: TOPICAL
Labeler: Healthy Directions, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-01
Substance: MENTHOL; METHYL SALICYLATE
Active strength: 25; 100 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70015-660-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70015-660-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70015-660-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70015-660-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70015-660-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70015-660-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70015-660-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70015-660-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70015-660-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70015-660-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70015-660-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70015-660-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70015-660-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70015-660-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70015-660-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70015-660-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70015-660-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70015-660-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70015-660-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70015-660-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70015-660-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70015-660-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70015-660-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70015-660-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70015-660-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70015-660-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70015-660-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70015-660-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70015-660-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70015-660-04	`1332a3947898…`	`d4bfe170f9cd…`

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: Instaflex Extra Strength Pain Relief Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	25 mg/g
METHYL SALICYLATE	100 mg/g

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
1148131	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
d058c64d-0e4f-45aa-8f52-804961b562e3	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70015-660-02	2024-01-30	C162847	48780-1	1030e365-39cc-111a-e063-dadaa90a10e2	Instaflex Extra Strength Pain Relief Cream
70015-660-04	2024-01-30	C162847	48780-1	1030e365-39cc-111a-e063-dadaa90a10e2	Instaflex Extra Strength Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70015-660-02	Instaflex Extra Strength Pain Relief Cream	57 g in 1 TUBE	CREAM	57	2
70015-660-02	Instaflex Extra Strength Pain Relief Cream	1 in 1 CARTON	CREAM	1	2
70015-660-04	Instaflex Extra Strength Pain Relief Cream	1 in 1 CARTON	CREAM	1	2
70015-660-04	Instaflex Extra Strength Pain Relief Cream	113 g in 1 TUBE	CREAM	113	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70015-660	INSTAFLEX EXTRA STRENGTH PAIN RELIEF CREAM (MENTHOL, METHYL SALICYLATE) CREAM [HEALTHY DIRECTIONS, LLC]	1	Current NDC, Legacy NDC, 4 package rows	20190301_d058c64d-0e4f-45aa-8f52-804961b562e3.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 108 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e5f3edc2-1b79-533a-e053-2a95a90ae9b6	2024-12-19	Warnings	Exact identifier application number: M017
Leader	LIDOCAINE HCL	Cardinal Health	cea6bd2d-a265-1209-e053-2995a90ab0a5	2024-12-19	Warnings	Exact identifier application number: M017
Rugby Anti-Itch	CAMPHOR, MENTHOL	RUGBY LABORATORIES	99d8ad9e-46ec-15fc-e053-2995a90a0d17	2024-12-19	Warnings	Exact identifier application number: M017
DCH Calaspray Itch Relief	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	fda2afaf-3cd0-92b3-e053-6394a90a7493	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief Roll-On	LIDOCAINE HCL 4%, MENTHOL 1%	Derma Care Research Labs, LLC	ff32cbb2-79eb-9158-e053-6394a90ac357	2024-12-19	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE, 0.5%	Derma Care Research Labs	ffd7be08-0510-dfcb-e053-6394a90ad286	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Pain Relief Roll-On	CAPSAISIN 0.1%	Derma Care Research Labs, LLC	fda0d359-95eb-8b38-e053-6294a90a7b88	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relieving	MENTHOL 2%	Derma Care Research Labs, LLC	ff49ee63-6a87-c7a7-e053-6294a90a77a3	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relief Roll-On Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	dd80e560-6467-2166-e053-2995a90a88a8	2024-12-19	Warnings	Exact identifier application number: M017
DCH Labs Cool and Heat Roll-On	MENTHOL 16%	Derma Care Research Labs, LLC	d35d7720-44ce-3624-e053-2995a90a7fb4	2024-12-19	Warnings	Exact identifier application number: M017
Dr Goldsons Pain	MENTHOL 8%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	fb34b0d3-ccc0-305e-e053-6394a90a231d	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relieving	CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	dd06af3c-5452-9759-e053-2a95a90afc21	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Burn Relief Aloe Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	ec6efa4b-dcbe-1c2b-e053-2995a90ae043	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Relief	TROLAMIN SALICYLATE 10%	Derma Care Research Labs, LLC	ff31e515-5780-b77d-e053-6394a90af6b9	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relief	LIDOCAINE 4%	Derma Care Research Labs, LLC	00efda74-d434-04be-e063-6294a90a6d98	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Cold Therapy Pain Relief	MENTHOL 5%	Dolgencorp, LLC	ff3284d1-e73c-93bf-e053-6294a90aaf4e	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Pain Relieving Patch with Lidocaine	LIDOCAINE	DOLGENCORP, LLC	55828cd1-3a1e-48ac-bb01-4c50b96d09a2	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief	LIDOCAINE 4%, MENTHOL 1%	Derma Care Research Labs, LLC	00db480a-e510-a64d-e063-6394a90a4695	2024-12-19	Warnings	Exact identifier application number: M017
Pain, Burn, and Itch Relief	BENZOCAINE 20%, MENTHOL 0.5%	Derma Care Research Labs, LLC	fd9fe09f-3ae9-c5f5-e053-6394a90ad691	2024-12-19	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 4%	Derma Care Research Labs, LLC	00ed3175-c3ba-6545-e063-6394a90acfd1	2024-12-19	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
1148131	menthol 2.5 % / methyl salicylate 10 % Topical Cream	PSN	d058c64d-0e4f-45aa-8f52-804961b562e3	2
1148131	menthol 25 MG/ML / methyl salicylate 100 MG/ML Topical Cream	SCD	d058c64d-0e4f-45aa-8f52-804961b562e3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70015-660-02	70015066002	1 TUBE in 1 CARTON (70015-660-02) / 57 g in 1 TUBE	1 tube	2019-03-01	0000-00-00	No	No	Current
70015-660-04	70015066004	1 TUBE in 1 CARTON (70015-660-04) / 113 g in 1 TUBE	1 tube	2019-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Instaflex Extra Strength Pain Relief Cream	Healthy Directions, LLC \| Pure Source, LLC	2026-05-11	HUMAN OTC DRUG LABEL	2