FDA.reportPublic FDA data

NDC 42452-378-49 - Revalife

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
42452-378
Requested NDC
42452-378-49
Package NDCs from labels
42452-378-49, 42452-378-48
Manufacturer
International Nutraceutical Company of America (INCA), LLC | International Nutraceutical Company of Americe (INCA), LLC
Effective date
2017-12-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DRUG FACTSInternational Nutraceutical Company of America (INCA), LLC | International Nutraceutical Company of Americe (INCA), LLC2017-12-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42452-378-482020-01-31C16284748780-19d75b9d0-c6a3-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42452-378-48Revalife1 in 1 CARTONOINTMENT12
42452-378-49Revalife85 g in 1 TUBEOINTMENT852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42452-378REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]2Legacy NDC, 2 package rows20171207_9e4585bc-273f-4e7b-b95e-ff61cde89cd9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AREVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3AREVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MREVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MREVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]1
N-ACETYLGLUCOSAMINEINACTIVE INGREDIENTV956696549REVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREVALIFE (TOPICAL MENTHOL) OINTMENT [INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC]1

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 4 of 255 · 5,083 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care MISTLETOE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.fca4510f-f130-464c-ade4-fe05bdae3e7b2026-09-01WarningsExact identifier
unii: 3K9958V90M
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: L7T10EIP3A
Smart Care Hand Sanitizer,2pk -Gingerbread and Cherry CobblerALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a52731b-5e8c-5ae6-e063-6394a90a8b042026-08-31WarningsExact identifier
unii: 3K9958V90M
REINREUDE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a539219-f9b8-5e94-e063-6294a90a25932026-08-31WarningsExact identifier
unii: L7T10EIP3A
SERYNTH SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a5405f9-9881-e547-e063-6294a90a0d102026-08-31WarningsExact identifier
unii: L7T10EIP3A
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f875e065-7b3e-45dc-8a33-b893ab8306952026-08-31WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30e11bf0-1a21-45b1-adf9-cf3845419a982026-08-31WarningsExact identifier
unii: 3K9958V90M
Swisher Instant Hand Sanitizer GelALCOHOLEcolab Inc.1f84e842-ece4-4eb7-9ccf-d86cec78dbf22026-08-31WarningsExact identifier
unii: 3K9958V90M
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
unii: L7T10EIP3A
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a4fb4b6-ba9e-5b82-e063-6294a90a47342026-08-30WarningsExact identifier
unii: 3K9958V90M
SYLVIRENE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a4fd689-2113-f15a-e063-6394a90a45ad2026-08-30WarningsExact identifier
unii: L7T10EIP3A
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a50402b-e4d7-3c0b-e063-6394a90a5e522026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a508fad-c7a4-82e8-e063-6294a90a0de12026-08-30WarningsExact identifier
unii: 3K9958V90M
Rhinoost SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a296baa-c101-3192-e063-6394a90aa2b02026-08-29WarningsExact identifier
unii: L7T10EIP3A
LUCKSKY SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a29ee19-8b6d-b4fa-e063-6394a90ad81d2026-08-29WarningsExact identifier
unii: L7T10EIP3A
Smart Care Hand Sanitizer with Beaded Wristlet - EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f160d3-7e42-ef07-e063-6394a90a6f8f2026-08-29WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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