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 128 of 131 · 2,601 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidothol	LIDOCAINE HCL, MENTHOL	Asclemed USA, Inc.	6d7adaca-67dd-4a4b-a85c-d1c2a568dee2	2022-09-09	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Alexso, Inc	5dbd5fc0-a27e-4979-aca7-28f73096fd5f	2022-08-18	Warnings	Exact identifier unii: L7T10EIP3A
Magnesia Muriatica	MAGNESIA MURIATICA	Hahnemann Laboratories, INC.	e45cf05f-7ca8-2654-e053-2a95a90a7425	2022-07-21		Exact identifier unii: 02F3473H9O
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Aewajin HasuoShampoo	MENTHOL, SALICYLIC ACID, PANTHENOL	MISOCOS	d4950ac9-8c05-989a-e053-2995a90ac6b7	2022-01-02	Warnings	Exact identifier unii: L7T10EIP3A
Treprostinil	TREPROSTINIL	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CONSTIPATION CP	ALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.	Natural Creations, Inc.	961b3ddf-41fe-46ed-b5e4-0fd8d9652edf	2021-11-15	Warnings	Exact identifier unii: 02F3473H9O
Magnesium Chloride	MAGNESIUM CHLORIDE	Mylan Institutional LLC	2105d1c1-54ef-4d1a-a63c-b1619e8b50db	2021-10-15	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
SPORTS gel	MENTHOL	Aloe Vera Korea Co.,Ltd.	c84fc51c-0e2c-56a2-e053-2995a90a077e	2021-08-03	Warnings	Exact identifier unii: L7T10EIP3A
CO COOL	MENTHOL, PEPPERMINT OIL, PINUS PUMILIO BRANCH/LEAF OIL	Lydia Co., Ltd.	90b213fe-f7b9-555c-e053-2a95a90a1df3	2021-06-27	Warnings	Exact identifier unii: AV092KU4JH unii: L7T10EIP3A
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
CLINIMIX E	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE	Baxter Healthcare Company	8469d6fb-d6ef-476f-8cc3-0905192de0a8	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O
GUNA THROAT AND GUMS	ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - WITCH HAZEL -	Guna spa	ba484531-ef7a-17ed-e053-2995a90a50b3	2021-02-17	Warnings	Exact identifier unii: 101I4J0U34
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Constipation	ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM	Newton Laboratories, Inc.	90807700-3099-850c-e053-2995a90ada55	2020-11-24	Warnings	Exact identifier unii: 02F3473H9O

Reported adverse events (FAERS/openFDA)#

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