FDA.reportPublic FDA data

NDC 76348-570-03 - AK47 Cooling Roll-On

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
76348-570
Requested NDC
76348-570-03
Package NDCs from labels
76348-570-03, 76348-570-01
Manufacturer
Renu Laboratories, Inc.
Effective date
2020-08-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AK4 7 Cooling Roll-On Pain ReliefRenu Laboratories, Inc.2020-08-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-570-012022-01-28C16284748780-1d6a99b39-cf94-a426-e053-dadaa90af4c2AK4 7 Cooling Roll-On Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-570-01AK47 Cooling Roll-On1 in 1 BOXLIQUID11
76348-570-03AK47 Cooling Roll-On84 g in 1 APPLICATORLIQUID841

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-570AK47 COOLING ROLL-ON (MENTHOL ROLL-ON) LIQUID [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20200812_ac9ba695-afa3-118f-e053-2a95a90a8168.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 35 of 165 · 3,288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Cold Therapy Pain RelievingMENTHOLWalmart Inc46a3c9e9-5cd3-4bc4-e063-6394a90a71782026-02-19WarningsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOLPerrigo Direct, Inc790843ce-88e2-4060-b61f-925fb30272da2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCAYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inc50776776-80aa-4098-8cf3-6daa0b305b152026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inccb4cf304-4f19-40cd-b480-9d89d19096842026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.bbf967e1-3a10-4e04-b7c5-2fcd80cc51742026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.41b8d113-59e0-41e3-b852-0ec7541cad802026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.ec4907e1-d31c-4360-97d9-dc094a5a08ac2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.2aacfe5c-36c8-4890-b6c0-a9511346761e2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aloe Vera GelLIDOCAINE HCL, MENTHOLMeijer, Inc.d0cc06c1-c0d5-42f0-82cd-8b704cbe1f462026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Witch HazelWITCH HAZELMeijer, Inc.13e4aece-5b91-4f89-a912-540bf170a8d12026-02-19Warnings, Adverse reactionsExact identifier
unii: 101I4J0U34
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.191f01bb-d580-4e96-89d4-ab736b75c51c2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4b1a0e6f-aa68-421c-e063-6294a90a426e2026-02-18WarningsExact identifier
unii: L7T10EIP3A
External Analgesic Cream with Menthol 5%MENTHOL 5%BLOOMWELL GARDENS LLC402faa27-5305-c73d-e063-6394a90a36f22026-02-18WarningsExact identifier
unii: L7T10EIP3A
PAINGELMENTHOL, METHYL SALICYLATENACOR BUSINESS GROUP LLC4b1d55e2-cf83-ffbd-e063-6294a90ad52f2026-02-18WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTarget Corporation563bdc23-7820-411a-b3c5-16514afc83d22026-02-18Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
cough suppressant and topical analgesicCAMPHOR, EUCALYPTUS OIL, MENTHOLTarget Corporationdf21d9d6-36a9-49cf-a29c-c4a573899bd52026-02-18Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTarget Corporation55e29b2f-a51f-4473-a022-aa9b921beb872026-02-18Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Isopropyl AlcoholISOPROPYL ALCOHOLTarget Corporationb5455e53-2b86-48e7-a479-664f6601bab72026-02-18Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Travel Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCdd046146-fda7-438c-98ca-96ea1dd0ae0b2026-02-18WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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