FDA.reportPublic FDA data

NDC 68229-601-01 - SunBurnt PLUS

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
68229-601
Requested NDC
68229-601-01
Package NDCs from labels
68229-601-01, 68229-601-02
Manufacturer
Quest Products, LLC. | Fill Tech USA
Effective date
2024-02-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SunBurnt PLUS - Quest Products, LLC. | Fill Tech USAQuest Products, LLC. | Fill Tech USA2024-02-23HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-601-01SunBurnt PLUS118 mL in 1 TUBEGEL1181
68229-601-02SunBurnt PLUS1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-601SUNBURNT PLUS (LIDOCAINE HYDROCHLORIDE) GEL [QUEST PRODUCTS, LLC.]1Current NDC, 2 package rows20240224_12128c75-015d-8a72-e063-6394a90ae00a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-601-01ML - Milliliter68229-6018752e6f0-3db0-470b-8321-8e2cd6cf719812026-03-17
68229-601-02ML - Milliliter68229-601289e306d-c317-4ebd-b495-aa1dc0126e9e12026-03-17

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 41 of 195 · 3,888 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alocane Anti-ItchHYDROCORTISONE 1%Quest Products, LLC45252043-d41a-3cdd-e063-6394a90aa9e52026-02-18WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEMedrock Pharmacy LLC43e00e17-1a48-43db-9589-834568917bbf2026-02-17WarningsExact identifier
application number: M017
Tylenol Precise Cooling Pain RelievingLIDOCAINE, MENTHOLKenvue Brands LLCfc0a3404-b174-3952-e053-6294a90a1e022026-02-16WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCLValu Merchandisers Company87ee2b4f-d640-4cec-9f48-1d8aa54434e92026-02-16Warnings, Adverse reactionsExact identifier
application number: M017
unii: V13007Z41A
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
unii: V13007Z41A
Hemp Magic Fast-Acting Pain Relief CreamMENTHOLNexxus Capital LLC4af69640-1413-868b-e063-6394a90a39892026-02-16WarningsExact identifier
application number: M017
RelaxInk LIDOCAINELIDOCAINE 4%Hambli Limited49a1cf66-9bb1-b918-e063-6394a90a2ff62026-02-15WarningsExact identifier
application number: M017
blue goo Pain RelievingMENTHOL 2.5%Garcoa, Inc.7b9b5ac6-9568-464c-8096-0302a1e650df2026-02-13WarningsExact identifier
application number: M017
Methyl Salicylate 30 Percent CreamMETHYL SALICYLATEAlexso, Inc1d50ccb2-1a5d-49c7-8524-2f54eed63e852026-02-13WarningsExact identifier
application number: M017
LMNOOP Wound CareWOUND CARE OINTMENTHunan Xiong Shi Pharmaceutical Co., Ltd193009cf-02bd-a187-e063-6294a90a5d752026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
ishancare wound careISHANCARE WOUND CARE OINTMENTHunan Xiong Shi Pharmaceutical Co., Ltd1aed8fef-e456-e6b6-e063-6294a90a57872026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
LMNOOP Wound CareWOUND CARE OINTMENTHunan Xiong Shi Pharmaceutical Co., Ltd8f096f20-b5b6-4b6c-e053-2a95a90a5cc42026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
ishancare bed and pressure soreISHANCARE BED AND PRESSURE SOREHunan Xiong Shi Pharmaceutical Co., Ltde8a28671-194a-69b5-e053-2995a90a49ab2026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
iShancare Diabetic Wounds and Sores CreamISHANCARE DIABETIC WOUND AND SORES CREAMHunan Xiong Shi Pharmaceutical Co., Ltd19bb986c-7797-9542-e063-6394a90a97542026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
perianal careLMNOOP PERIANAL CARE OINTMENTHunan Xiong Shi Pharmaceutical Co., Ltd192ee5a6-0023-71a1-e063-6294a90ab1232026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLTopco Associates LLCa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLTopco Associates LLC80962394-a46f-48fd-8e0c-685dd1e500d72026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
BanophenDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMajor Pharmaceuticals9758d886-bd58-4eb2-a827-fa8e7fee2b7c2026-02-13WarningsExact identifier
application number: M017
Natureplex Hydrocortisone HydroHYDROCORTISONENatureplex, LLC2fc6a148-34bb-4289-8588-32c1bb011b982026-02-13WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINAlexso, Inc6d0bc1cc-e812-4753-b20c-c0357dd6deb52026-02-13WarningsExact identifier
application number: M017

Reported adverse events (FAERS/openFDA)#

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