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 13 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sabharwals	METHYL SALICYLATE 10% GEL PATCH	Dr. Sabharwal's Wound Care	4a7790bb-25cb-72b8-e063-6294a90a6b9c	2026-06-29	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Target Corporation	36602b7a-99c0-f6a4-e063-6294a90a8758	2026-06-29	Warnings	Exact identifier application number: M017
FIRST SHIELD	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Unishield	f86f7446-b741-9f40-e053-6394a90a4422	2026-06-29	Warnings	Exact identifier application number: M017
MQ Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5560cdab-cee8-f6ec-e063-6294a90ad024	2026-06-29	Warnings	Exact identifier application number: M017
GNP Lidocaine Maximum Strength	LIDOCAINE HCL	AMERISOURCE BERGEN	9f559c20-c9ac-e480-e053-2a95a90a8fce	2026-06-29	Warnings	Exact identifier application number: M017
NUMBING	LIDOCAINE	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	5553385d-c1e6-1242-e063-6394a90aa5a7	2026-06-28	Warnings	Exact identifier application number: M017
MOROVAN	LIDOCAINE	HONG KONG UNORDERED TRADING CO., LIMITED	550c8d2d-e0d7-1531-e063-6394a90a374d	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas, LLC	5517ee5f-1c51-cfd6-e063-6294a90af56f	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas LLC	55188ede-68cd-fcc6-e063-6394a90a5c58	2026-06-25	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	NuCare Pharmaceuticals, Inc.	54f07a23-213f-ca46-e063-6394a90a0034	2026-06-24	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION	MENTHOL,PRAMOXINE HYDROCHLORIDE	Rida LLC	b62d09e4-7ced-49a9-8c83-3a8ef580f25a	2026-06-23	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION	PRAMOXINE HYDROCHLORIDE	Rida LLC	5b2cb1bd-2f1e-4670-b40e-6c058bfd12a2	2026-06-23	Warnings	Exact identifier application number: M017
Pain Relieving cleansing spary	BENZALKONIUM CHLORIDE AND LIDOCAINE HCI	Trifecta Pharmaceuticals USA, LLC.	48edbb8d-0c35-91d8-e063-6394a90a71b8	2026-06-19	Warnings	Exact identifier application number: M017
Pain Relief	MENTHOL	Trifecta Pharmaceuticals USA, LLC.	493ab515-5cda-7b5a-e063-6294a90a295b	2026-06-19	Warnings	Exact identifier application number: M017
Tiger Balm Muscle Rub	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)	Haw Par Healthcare Ltd.	011fc383-10bc-44cf-a67c-4be45fef33e0	2026-06-19	Warnings	Exact identifier application number: M017
CVS Health Scalp Relief	SALICYLIC ACID	CVS Health	8de46015-817c-4cd9-95f8-293424f2a5c4	2026-06-19	Warnings	Exact identifier application number: M017
Careland Kinesiology Dual Action Pain Relieving Tape	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	67e0b3c5-e88e-4c48-a1e8-39f502ac249d	2026-06-18	Warnings	Exact identifier application number: M017
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	549348ec-2eb2-3781-e063-6294a90a2f4a	2026-06-18	Warnings	Exact identifier application number: M017
SprayPain Away	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	c603e999-2316-496a-e053-2995a90ab4ed	2026-06-17	Warnings	Exact identifier application number: M017
SprayPain Away Lavender	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	547e2167-ade0-ac7e-e063-6294a90a18ea	2026-06-17	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