Instaflex Pain Relief Cream

Product NDC: 70015-665
11-digit product format: 700150665
Labeler code: 70015
Product ID: 70015-665_51a0db5e-9e53-71c2-e063-6394a90a1bb2
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Healthy Directions, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-01-01
Substance: MENTHOL
Active strength: 12.5 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 · 60 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	70015-665-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70015-665-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70015-665-02	`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	70015-665-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70015-665-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70015-665-02	`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	70015-665-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70015-665-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70015-665-02	`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	70015-665-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70015-665-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70015-665-02	`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	70015-665-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70015-665-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70015-665-02	`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	70015-665-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70015-665-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70015-665-02	`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	70015-665-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70015-665-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70015-665-02	`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	70015-665-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70015-665-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70015-665-02	`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	70015-665-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70015-665-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70015-665-02	`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	70015-665-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70015-665-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70015-665-02	`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	70015-665-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70015-665-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70015-665-02	`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	70015-665-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70015-665-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70015-665-02	`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	70015-665-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70015-665-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70015-665-02	`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	70015-665-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70015-665-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70015-665-02	`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	70015-665-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70015-665-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70015-665-02	`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 Pain Relief Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	12.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416982	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
665b847a-9cfb-49fc-975b-81c97f936575	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70015-665-01	2024-01-30	C162847	48780-1	1030e365-35e7-111a-e063-dadaa90a10e2	Instaflex Pain Relief Cream
70015-665-02	2024-01-30	C162847	48780-1	1030e365-35e7-111a-e063-dadaa90a10e2	Instaflex Pain Relief Cream
70015-665-04	2024-01-30	C162847	48780-1	1030e365-35e7-111a-e063-dadaa90a10e2	Instaflex Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70015-665-01	Instaflex Pain Relief Cream	28 g in 1 TUBE	CREAM	28	3
70015-665-01	Instaflex Pain Relief Cream	1 in 1 CARTON	CREAM	1	3
70015-665-02	Instaflex Pain Relief Cream	1 in 1 CARTON	CREAM	1	3
70015-665-02	Instaflex Pain Relief Cream	57 g in 1 TUBE	CREAM	57	3
70015-665-04	Instaflex Pain Relief Cream	113 g in 1 TUBE	CREAM	113	3
70015-665-04	Instaflex Pain Relief Cream	1 in 1 CARTON	CREAM	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70015-665	INSTAFLEX PAIN RELIEF CREAM (MENTHOL) CREAM [HEALTHY DIRECTIONS, LLC]	2	Current NDC, Legacy NDC, 6 package rows	20200611_665b847a-9cfb-49fc-975b-81c97f936575.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 101 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortizone 10 Soothing Aloe Itch Relief	HYDROCORTISONE	Chattem, Inc.	1962abb3-6ca7-4934-9efe-20287b1c2a5b	2025-02-01	Warnings	Exact identifier application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol	MENTHOL	Inspec Solutions LLC	d4276749-eeff-28f7-e053-2a95a90a593d	2025-01-31	Warnings	Exact identifier application number: M017
MyDerm Bite Relief	BENZOCAINE	Inspec Solutions LLC.	88615668-16b5-7840-e053-2a95a90a9208	2025-01-31	Warnings	Exact identifier application number: M017
Maximum Strength Blue Emu Pain Relief Blu Emu	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	5e02b820-e53a-42cb-abdb-2925617c29ca	2025-01-31	Warnings	Exact identifier application number: M017
Sunset Novelties Herquake	NUMBING LUBRICANT	SUNSET INTIMATES GROUP INC	2ceeca3e-9197-9166-e063-6394a90ae908	2025-01-30	Warnings	Exact identifier application number: M017
Magsoothium CBD Cooling Roll on Relief	MENTHOL	Ubu/Elements, Inc.	2cf05dcd-6a44-de08-e063-6394a90aaba0	2025-01-30	Warnings	Exact identifier application number: M017
Meijer Vagicaine	20% BENZOCAINE AND 3% RESORCINOL CREAM	Meijer, Inc.	dac73a07-7569-4788-977a-f10d098da75d	2025-01-30	Warnings	Exact identifier application number: M017
ZCort Ultra	HYDROCORTISONE ACETATE 1%	RxDino, LLC	b68f8ada-58e8-e8e4-e053-2a95a90ab02d	2025-01-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieving Gel-Patch	LIDOCAINE 4%	Noble OTC LLC	12a3ce63-6fce-0993-e063-6294a90a40d5	2025-01-28	Warnings	Exact identifier application number: M017
INTIMALE LIDOCAINE DELAY	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	5ddd7d56-bf51-462b-afcd-944861e49781	2025-01-28	Warnings	Exact identifier application number: M017
CBD Clinic Relax Massage	CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0eae24e-09cf-0d2d-e053-2a95a90acedc	2025-01-28	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 5	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0ebbc0f-9888-b812-e053-2a95a90a5d3d	2025-01-28	Warnings	Exact identifier application number: M017
CBDMEDIC Arthritis Aches and Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec7255-bb36-41cd-e053-2a95a90aeac4	2025-01-28	Warnings	Exact identifier application number: M017
CBDMEDIC Back and Neck Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec8fc9-c401-5f23-e053-2995a90acb1c	2025-01-28	Warnings	Exact identifier application number: M017
Muscle Therapy	METHYL SALICYLATE, CAMPHOR	Everlaan Organics Inc	0890a683-9a66-fdbd-e063-6294a90ae526	2025-01-27	Warnings	Exact identifier application number: M017
Joint Therapy	CAMPHOR	Everlaan Organics Inc	08904b77-d6db-8b82-e063-6394a90ace4f	2025-01-27	Warnings	Exact identifier application number: M017
Warrior Arthritis Relief	TROLAMIN SALICYLATE 10%	Derma Care Research Labs, LLC	013f48b9-913f-b283-e063-6394a90abd73	2025-01-27	Warnings	Exact identifier application number: M017
DCH Cool and Heat	MENTHOL 16%	Derma Care Research Labs, LLC	ff323282-612c-eaf8-e053-6394a90ab779	2025-01-27	Warnings	Exact identifier application number: M017
Gerigentle	HYDROCORTISONE	GERI-GENTLE CORPORATION	0adfa2f0-9758-5c54-e063-6294a90a461f	2025-01-25	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving	MENTHOL, CAMPHOR	Active and Innovative Inc.	42f1abeb-f6d7-01c3-e054-00144ff88e88	2025-01-23	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416982	menthol 1.25 % Topical Cream	PSN	665b847a-9cfb-49fc-975b-81c97f936575	3
416982	menthol 12.5 MG/ML Topical Cream	SCD	665b847a-9cfb-49fc-975b-81c97f936575	3
416982	menthol 1.25 % Topical Cream	SY	665b847a-9cfb-49fc-975b-81c97f936575	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70015-665-01	70015066501	1 TUBE in 1 CARTON (70015-665-01) / 28 g in 1 TUBE	1 tube	2020-06-10	0000-00-00	No	No	Current
70015-665-02	70015066502	1 TUBE in 1 CARTON (70015-665-02) / 57 g in 1 TUBE	1 tube	2019-01-01	0000-00-00	No	No	Current
70015-665-04	70015066504	1 TUBE in 1 CARTON (70015-665-04) / 113 g in 1 TUBE	1 tube	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Instaflex Pain Relief Cream	Healthy Directions, LLC \| Pure Source, LLC	2026-05-12	HUMAN OTC DRUG LABEL	3