Instaflex Pain Relief Cream

Product NDC: 70015-665
Requested package NDC: 70015-665-02
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 · 15 matching rows.

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

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

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 1 of 154 · 3,068 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Cardinal Health, 110 dba Leader	3ed7b8a1-012f-459d-878c-813b93d4673c	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Gel Cooling Pain Relief	MENTHOL	The Kroger Co.	6fb0acc8-8dab-452c-b09e-de97306e1c32	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Lidocaine Tattoo Wipe	LIDOCAINE HYDROCHLORIDE	MD Tattoo Company	369c1d16-597c-e1dc-e063-6394a90a3104	2026-08-06	Warnings	Exact identifier application number: M017
Point Relief Coldspot Pain Relieving	MENTHOL	Fabrication Enterprises Inc	479fb728-4aeb-42e3-b238-f04255514baa	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine HCl	LIDOCAINE HCL	Topco Associates LLC	584e1f35-4d99-9c85-e063-6294a90ab3d0	2026-08-05	Warnings, Adverse reactions	Exact identifier application number: M017
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	56e36592-a935-61d4-e063-6294a90a6e4c	2026-08-04	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Menthol Pain Relief	MENTHOL	Carlin Consumer Health LLC	584f5c6e-3385-3221-e063-6294a90aabae	2026-08-04	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	2026-08-04	Warnings	Exact identifier application number: M017
procure	HYDROCORTISONE ACETATE	TWIN MED, LLC	2670c9c4-66ad-40e8-a08a-582b160de39d	2026-08-03	Warnings	Exact identifier application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Alphamale Delay Cream	BENZOCAINE	Prodigy Media Inc	53d682ee-0802-a16d-e063-6394a90aeee1	2026-07-31	Warnings	Exact identifier application number: M017
Pure Primal Delay Cream	BENZOCAINE	Prodigy Media Inc	57e9e894-c14f-d806-e063-6394a90ab8e5	2026-07-31	Warnings	Exact identifier application number: M017
Satohap	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	df0e2b83-8f61-4ed8-bcc4-55e4ea782090	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	cb000134-92a4-4304-8ef0-0347190e1414	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic Hot	CAPSAICIN	Sato Pharmaceutical Co., Ltd.	16b47cb5-ea5f-4514-9a89-141ee4cc60f8	2026-07-31	Warnings	Exact identifier application number: M017
Satohap Cool and Hot Pads	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceutical Co., Ltd.	b6bf1eab-4ab9-f500-e053-2995a90a8d7b	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
SATOHAP COOL and HOT	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceuticals Co., Ltd.	232a4c76-1a0c-2f4b-e063-6394a90a8849	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	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
70015-665-02	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

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