NDC 76348-522-04 - AK47 MENTHOL COOLING

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 76348-522
Requested NDC: 76348-522-04
Package NDCs from labels: 76348-522-04, 76348-522-01
Manufacturer: RENU LABORATORIES, INC.
Effective date: 2020-07-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
AK4 7 Menthol Cooling Pain Relief Cream	RENU LABORATORIES, INC.	2020-07-23	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-522-01	2022-01-28	C162847	48780-1	d6a99b39-43c4-a426-e053-dadaa90af4c2	AK4 7 Menthol Cooling Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-522-01	AK47 MENTHOL COOLING	1 in 1 BOX	CREAM	1		2
76348-522-04	AK47 MENTHOL COOLING	112 g in 1 JAR	CREAM	112		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-522	AK47 MENTHOL COOLING (MENTHOL COOLING) CREAM [RENU LABORATORIES, INC.]	2	Legacy NDC, 2 package rows	20200724_aae3c43a-3839-01ce-e053-2a95a90a885c.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 130 of 131 · 2,601 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Avedana Cool Hot Ice	MENTHOL	Unipack, Inc.	619c8e3f-0cad-4eb1-8dbb-632f3db74ba3	2018-05-01	Warnings	Exact identifier unii: L7T10EIP3A
Pure-Aid	LIDOCAINE, MENTHOL	Kareway Product, Inc.	6679cada-f083-26e8-e053-2a91aa0adcc5	2018-03-02	Warnings	Exact identifier unii: L7T10EIP3A
Ivy-Dry Super	BENZYL ALCOHOL, CAMPHOR, MENTHOL	Ivy-Dry, Inc.	4792a667-2378-4b3d-968d-9efb1866792f	2017-12-27	Warnings	Exact identifier unii: L7T10EIP3A
ICY FREEZE	MENTHOL	NATURAL ESSENTIALS, INC.	41b2e9a0-818d-4188-8c9d-8ff7c0d0519b	2017-12-01	Warnings	Exact identifier unii: L7T10EIP3A
Sugar Free Cherry Cough Drops	MENTHOL	Army & Air Force Exchange Service	5d7f7e45-7d69-10dc-e053-2991aa0a389c	2017-11-08	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine Pain Relief Patch	LIDOCAINE AND MENTHOL, UNSPECIFIED FORM	Foshan Aqua Gel Biotech Co.,Ltd.	3fe1a160-6508-62ea-e054-00144ff8d46c	2017-11-06	Warnings	Exact identifier unii: L7T10EIP3A
Ultimate Topical Pain Relief Patch	CAPSAICIN AND MENTHOL, UNSPECIFIED FORM	Foshan Aqua Gel Biotech Co.,Ltd.	33c9f8ba-903e-249e-e054-00144ff8d46c	2017-11-06	Warnings	Exact identifier unii: L7T10EIP3A
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Dollar General Medicated Pain Relief Patch	CAMPHOR, MENTHOL, METHYL SALICYLATE	DOLGENCORP, LLC	86b0bd7b-c31c-4c35-a5da-0deac9558abe	2017-10-01	Warnings	Exact identifier unii: L7T10EIP3A
Assured Vaporizing Chest Rub	CAMPHOR AND EUCALYPTUS OIL AND MENTHOL	Greenbrier International, Inc.	24fdad60-490d-6dc5-e054-00144ff8d46c	2017-08-31	Warnings	Exact identifier unii: L7T10EIP3A
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Studio 35 External Analgesic Medicated Body	MENTHOL AND ZINC OXIDE	Walgreen Co	2dd63063-45c1-4029-99ac-0962a27a5ddc	2017-02-08	Warnings	Exact identifier unii: L7T10EIP3A
CVS Sore Muscle Rub Vanishing Scent	MENTHOL	CVS Pharmacy	454bbde9-3076-6977-e054-00144ff88e88	2017-01-04	Warnings	Exact identifier unii: L7T10EIP3A
Professional Therapy MuscleCare Turbo	MENTHOL, CAMPHOR	Active and Innovative Inc.	42f1e14a-3ac6-01c1-e054-00144ff8d46c	2016-12-05	Warnings	Exact identifier unii: L7T10EIP3A
Dr. Blue	MENTHOL	Indiana Botanic Gardens	1b1150bd-e087-4d8f-b0d6-0d935cf6e31e	2016-11-01	Warnings	Exact identifier unii: L7T10EIP3A
Professional Therapy MuscleCare	CAMPHOR, MENTHOL	Active and Innovative Inc.	1ec95bbb-cd7d-2588-e054-00144ff8d46c	2016-08-11	Warnings	Exact identifier unii: L7T10EIP3A
Professional Therapy MuscleCare pain relieving gel Extra Strength	CAMPHOR, MENTHOL	Active and Innovative Inc.	1d2403d9-99c3-24f5-e054-00144ff8d46c	2016-08-10	Warnings	Exact identifier unii: L7T10EIP3A
MED AID CHEST RUB	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Blue Cross Laboratories, Inc.	429041fe-55a5-4df1-b60d-721103e5c65e	2016-07-27	Warnings	Exact identifier unii: L7T10EIP3A
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	567b6820-fb52-630e-e063-6294a90a8bf8	2015-07-01	Warnings	Exact identifier unii: AV092KU4JH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.