FDA.reportPublic FDA data

NDC 76348-615-03 - REMEDY Pain Relief Cooling Menthol 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
76348-615
Requested NDC
76348-615-03
Package NDCs from labels
76348-615-03, 76348-615-01
Manufacturer
RENU LABORATORIES, INC.
Effective date
2021-05-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
REMEDY COOLING MENTHOL ROLL ONRENU LABORATORIES, INC.2021-05-10HUMAN OTC DRUG LABEL

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 122 of 190 · 3,786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC9067c301-74f9-457a-9b0f-b7e9b06a35082025-02-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Halls Sugar Free CherryMENTHOLMondelez Global LLCea8dfe96-f6a4-4172-bf9e-ae3cf606ff502025-02-14WarningsExact identifier
unii: L7T10EIP3A
Halls Sugar Free WatermelonMENTHOLMondelez Global LLCc4c090ca-f083-74e0-e053-2a95a90a9d602025-02-14WarningsExact identifier
unii: L7T10EIP3A
50 percent Isopropyl alcoholISOPROPYL ALCOHOLWhole Foods Market6cb4ccca-96e7-43cb-ae05-95a411e712552025-02-14WarningsExact identifier
unii: ND2M416302
Rubbing Alcohol 91 percent isopropylISOPROPYL ALCOHOLWinCo Foods, LLC0ce2110d-ea9d-4d41-b0ae-6e9182f25abc2025-02-12WarningsExact identifier
unii: ND2M416302
Vaporizing Chest Rub 4 oz.CAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.7173b141-123e-6cd4-e053-2a95a90a86002025-02-12WarningsExact identifier
unii: L7T10EIP3A
Vaporizing Chest Rub 4 oz. 3 pkCAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.71c186a1-8283-2482-e053-2995a90acc1f2025-02-12WarningsExact identifier
unii: L7T10EIP3A
Witch Hazel ReadyInCaseWITCH HAZELP & L Development, LLC1588244a-c9e8-4a04-b605-10e35c225e6c2025-02-12WarningsExact identifier
unii: 101I4J0U34
Arnica 6cARNICA MONTANASEVENE USAdb2ab5f5-3ba8-482d-bb16-4f1e4c661b882025-02-11WarningsExact identifier
unii: O80TY208ZW
Muscle EaseCHAMOMILLA, PHYTOLACCA DECANDRA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARGENTUM NITRICUM, ARNICA MONTANA, BRYONIA, CHAMOMILLA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, EUPATORIUM PERFOLIATUM, HYPERICUM PERFORATUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, STRAMONIUM, STRYCHNINUM.Newton Laboratories, Inc.9c5b8025-9c59-997e-e053-2a95a90ac6ce2025-02-11WarningsExact identifier
unii: O80TY208ZW
KT HELATH SOOTHE MAGNESIUM, LAVENDERARNICA MONTANA WHOLEKT Health LLC1d993fe0-2c46-426c-8922-388723e744f42025-02-10WarningsExact identifier
unii: O80TY208ZW
ARNICA 30CARNICA MONTANASEVENE USA35b232db-66c8-4e4e-a9d4-a6f52f503dc62025-02-10WarningsExact identifier
unii: O80TY208ZW
ARNICA MONTANAARNICA MONTANASEVENE USA5e840b32-ea22-437f-acd9-46011733e6432025-02-10WarningsExact identifier
unii: O80TY208ZW
Arnica 12cARNICA MONTANASEVENE USA4a855e74-3553-481c-a926-572a079e6ac82025-02-10WarningsExact identifier
unii: O80TY208ZW
ARNICAARNICA MONTANASEVENE USA5816458e-57dc-4c50-a48c-1e315ca47c992025-02-10WarningsExact identifier
unii: O80TY208ZW
Prevantics SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.9841200b-d4c6-b40c-e053-2995a90a55962025-02-10WarningsExact identifier
unii: ND2M416302
Sports RecoveryECHINACEA, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, APIS MELLIFICA, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CINCHONA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, LACTICUM ACIDUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, STAPHYSAGRIA, SYMPHYTUM OFFICINALENewton Laboratories, Inc.9cd61789-fc2b-3d54-e053-2995a90a5a342025-02-10WarningsExact identifier
unii: O80TY208ZW
Swimmers FriendANTIMONIUM TART., ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, DIGITALIS PURPUREA, DROSERA, LACHESIS MUTUS, LACTICUM ACIDUM, LEDUM PALUSTRE, MAGNESIA CARBONICA, MANGANUM ACETICUM, NUX VOMICA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHURICUM ACIDUM, VERBASCUM THAPSUS, VIPERA BERUSNewton Laboratories, Inc.9d260197-0c81-0df2-e053-2a95a90a44102025-02-10WarningsExact identifier
unii: O80TY208ZW
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d27b1e4-a966-5495-e053-2a95a90a965b2025-02-10WarningsExact identifier
unii: O80TY208ZW
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d363a40-a17b-2b6f-e053-2a95a90a33842025-02-10WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

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