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 98 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	3a36a241-37a9-445a-a6e0-97709a7457a8	2025-03-19	Warnings	Exact identifier application number: M017
Herb Analgesic	HERB ANALGESIC PASTE	Changsha Maocheng Trading Co., Ltd	29373587-9eff-6ea0-e063-6394a90a23b2	2025-03-18	Warnings	Exact identifier application number: M017
DEBACHERE Butt Balm After Play Care Multi Symptoms Relief	BENZOCAINE, BENZALKONIUM CHLORIDE	DE.BACHERE USA LLC	f469b446-58a0-4be3-884f-d622b9d074f8	2025-03-17	Warnings	Exact identifier application number: M017
Auvon 4% Menthol Pain Relief Gel	MENTHOL	SHENZHEN YUWEN E-COMMERCE CO., LTD.	2dacd6fe-7d69-bcf0-e063-6294a90a0351	2025-03-14	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	2025-03-14	Warnings	Exact identifier application number: M017
AY BENDITO THERMOACTIVE	MENTHOL, CAMPHOR	AY BENDITO INTERNATIONAL, INC	304d71b6-91c8-b2b6-e063-6394a90ab669	2025-03-14	Warnings	Exact identifier application number: M017
Hot/Cold Medicated Patch	HOT COLD PATCH	Dynarex	999881b3-287e-d975-e053-2995a90a87e3	2025-03-14	Warnings	Exact identifier application number: M017
Capsaicin 0.025%	CAPSAICIN 0.025%	Marcella Health	3054e7fd-cab2-7f77-e063-6294a90a498d	2025-03-14	Warnings	Exact identifier application number: M017
MENTHOL 5%	MENTHOL 5%	Marcella Health	30914c0a-fbda-5674-e063-6294a90aba5b	2025-03-14	Warnings	Exact identifier application number: M017
Peppermint Soothing Patch	CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM	Henan Lijitang Medical Technology Co., Ltd.	30361dd4-1f3d-ac5e-e063-6294a90a23bc	2025-03-13	Warnings	Exact identifier application number: M017
AVCOO Menthol Pain Relief Patch	MENTHOL	ADP Health Limited	3036804b-16c3-0c88-e063-6394a90a3084	2025-03-13	Warnings	Exact identifier application number: M017
LIDOCAINE 4%	LIDOCAINE 4%	Marcella Health	303d9462-cbfb-6251-e063-6394a90a7065	2025-03-13	Warnings	Exact identifier application number: M017
XeroBurn Burn Gel	LIDOCAINE HYDROCHLORIDE	Dynarex Corporation	58985046-ca9c-12be-e053-2991aa0abe72	2025-03-13	Warnings	Exact identifier application number: M017
Post Treatment Repair Cream	HYDROCORTISONE	Vege Labs LLC.	302d4327-354b-a252-e063-6394a90a20b6	2025-03-12	Warnings	Exact identifier application number: M017
TheraCare Pain Relief 4% Lidocaine	LIDOCAINE	Veridian Healthcare	2d3fc030-5d53-2acd-e063-6294a90a11ab	2025-03-11	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	Veridian Healthcare	2d413707-794c-2fa8-e063-6394a90a06bf	2025-03-11	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	Veridian Healthcare	2d04799f-946d-ac53-e063-6294a90afeb7	2025-03-11	Warnings	Exact identifier application number: M017
Muscle and Joint Care	LIDOCAINE	Vege Labs LLC.	301966b5-b535-dc04-e063-6394a90aec17	2025-03-11	Warnings	Exact identifier application number: M017
Arctic Blast Pain Releiving	MENTHOL, CAMPHOR (SYNTHETIC)	Nutriomo Labs Pte, Ltd	d5e7d26d-4f63-4b7b-a173-fe3a794c8459	2025-03-10	Warnings	Exact identifier application number: M017
Anti Itch	WALGREEN	Walgreens	30014ff0-2519-4031-e063-6394a90ae07b	2025-03-10	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