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 102 of 237 · 4,730 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Absolut Skin Corticosoothe Anti-ItchHYDROCORTISONEAbsolut Skin Incorporateddeb52218-9176-4aaa-a22f-b66dada6690f2025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor PharmacyLIDOCAINEInterMed Laboratories Private Limited43f3d189-f6b7-02ed-e063-6394a90afd732025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch HealthA2ZLIDOCAINEInterMed Laboratories Private Limited43f3e288-e828-8130-e063-6394a90a6d442025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch LeaderLIDOCAINEInterMed Laboratories Private Limited42f06914-c8b8-ea9c-e063-6294a90a79e62025-11-19WarningsExact identifier
application number: M017
Dukal Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC953b0dd6-a667-4146-815e-6845aba0309b2025-11-19WarningsExact identifier
unii: ND2M416302
Dukal Sterile Alcohol SwabstickISOPROPYL ALCOHOLDukal LLC8e47e9ad-cea4-76a4-e053-2a95a90ae7802025-11-19WarningsExact identifier
unii: ND2M416302
CVS Anti-ItchCAMPHOR, MENTHOLCVS87715662-c788-9a8d-e053-2a95a90acb532025-11-19WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Walgreen Anti ItchCAMPHOR, MENTHOLWalgreensb4f47a8d-d4a6-9233-e053-2a95a90afd902025-11-19WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Leader Anti-ItchCAMPHOR, MENTHOLLEADER/Cardinal Helath 110, Inc.9ca985c6-5017-0558-e053-2995a90a82022025-11-19WarningsExact identifier
application number: M017
unii: L7T10EIP3A
CVS Anti-ItchPRAMOXINE HCLCVS87fc476a-5b12-7383-e053-2995a90a530b2025-11-19WarningsExact identifier
application number: M017
Walgreen Anti-ItchPRAMOXINE HCLWalgreensb5f9d1c5-891e-4377-e053-2995a90aa2812025-11-19WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF89f5f688-856f-f2df-e053-2995a90a73cf2025-11-19WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Itch EraserDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands2204e135-6a23-68a2-e063-6394a90ac0192025-11-18WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpc8594e10-661f-6ff3-e053-2995a90ab4fc2025-11-18WarningsExact identifier
application number: M017
unii: L7T10EIP3A
unii: LAV5U5022Y
Mag 5 PT Cooling Formula Recovery CreamMENTHOLRENU LABORATORIES, LLCa45cde67-64ec-643b-e053-2a95a90a10b62025-11-18WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQUALITY CHOICE (Chain Drug Marketing Association)c0e3c959-bed6-2ce5-e053-2995a90a0be92025-11-17WarningsExact identifier
unii: L7T10EIP3A
unii: 2R04ONI662
After Ivy WipeCAMPHORTender Corporation d/b/a Adventure Ready Brands21d98018-826a-1d0d-e063-6294a90a0a712025-11-17WarningsExact identifier
application number: M017
Itch Eraser GelDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands223c7cfd-6dc5-140a-e063-6394a90a83322025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
application number: M017

Reported adverse events (FAERS/openFDA)#

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