FDA.reportPublic FDA data

NDC 69574-005-04 - NOVUM APR

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
69574-005
Requested NDC
69574-005-04
Package NDCs from labels
69574-005-04, 69574-005-05
Manufacturer
NOVUM SOLUTIONS INC | Bio-Medical & Pharmaceutical Manufacturing Corporation
Effective date
2025-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NOVUM APR - NOVUM SOLUTIONS INC | Bio-Medical & Pharmaceutical Manufacturing CorporationNOVUM SOLUTIONS INC | Bio-Medical & Pharmaceutical Manufacturing Corporation2025-04-07HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-04-071b869a1f-5787-4d03-a546-43a8217b2b2c
2025-01-301b869a1f-5787-4d03-a546-43a8217b2b2c
2023-11-031b869a1f-5787-4d03-a546-43a8217b2b2c
2023-01-301b869a1f-5787-4d03-a546-43a8217b2b2c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69574-005-04NOVUMAPR118.3 mL in 1 BOTTLE, SPRAYSPRAY118.37
69574-005-05NOVUMAPR1 in 1 BOXSPRAY17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69574-005NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]7Current NDC, Legacy NDC, 2 package rows20250409_1b869a1f-5787-4d03-a546-43a8217b2b2c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ANOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]3
MENTHOLACTIVE MOIETYL7T10EIP3ANOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]3
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YNOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]3
SPEARMINT OILINACTIVE INGREDIENTC3M81465G5NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]3
WATERINACTIVE INGREDIENT059QF0KO0RNOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]3

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 58 of 239 · 4,770 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDiscount Drug Mart2075ed67-bb89-41bc-98bc-a6ab2262bdc72026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDiscount Drug Mart53526652-49ac-411b-8906-74f2ad4b64762026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Isopropyl AlcoholISOPROPYL ALCOHOLDyad Medical Sourcing, LLCb5c9e222-10eb-4cea-af70-213a77fcc8652026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLGoBrands, Inc.0fb3db50-4132-07dc-e063-6294a90a81682026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLGrocery Outlet, Inc.3dff8c83-7c33-7bca-e063-6394a90a675f2026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLGrocery Outlet, Inc.3dffba95-71c4-a2b0-e063-6394a90aaeb32026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Antiseptic Mouth RinseEUCALYPTOLHARRIS TEETERf96372a9-2fb5-4ba6-8b3e-541c8e6e2cf62026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHarris Teeter9fb0fa91-282a-440d-9d1d-c868a5978ee32026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHARRIS TEETER98728688-32f6-44f1-9cc9-cd72c3a039ad2026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLHy-Vee, Inc.446de381-6685-748d-e063-6394a90a1b732026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: 2R04ONI662
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHy-Vee, Inc.4538029b-1ff9-080a-e063-6394a90ac9b72026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
91% ISOPROPYL ALCOHOL91% ISOPROPYL ALCOHOLHy-Vee, Inc.497471bb-541c-f945-e063-6294a90adbb22026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLHy-Vee, Inc.4831eecf-d111-6f17-e063-6394a90a4ab92026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLLidl US, LLCc3bd0ca6-3f42-423b-92ac-c7f8fc09152b2026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLMarc Glassman, Inc47339eeb-8097-498a-ba4e-a73de477aa182026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMarc Glassman, Ince668364b-907b-48fc-9fb2-97619607506b2026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMarc Glassman, Incf0ac9715-7d9f-48e9-9371-bb7d8be29c662026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLCHEMCO CORPORATION4a05f02e-e882-2cb2-e063-6394a90ad3282026-02-04WarningsExact identifier
application number: M017
unii: L7T10EIP3A
unii: LAV5U5022Y
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4a065965-43bd-e0e3-e063-6294a90ad76a2026-02-04WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a0969d3-1f06-3ba7-e063-6294a90a86272026-02-04WarningsExact identifier
application number: M017
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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