FDA.reportPublic FDA data

NDC 27293-012-14 - Oral Gel Maximum Strength

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
27293-012
Requested NDC
27293-012-14
Package NDCs from labels
27293-012-14, 27293-012-01
Manufacturer
Budpak Inc. | Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.
Effective date
2010-01-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oral Gel Maximum StrengthBudpak Inc. | Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.2010-01-16HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
27293-012-012019-10-21C16284748780-1956f9ecf-d1e2-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27293-012-01Oral GelMaximum Strength1 in 1 BOXGEL11
27293-012-14Oral GelMaximum Strength14 g in 1 TUBEGEL141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27293-012ORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1Legacy NDC, 2 package rows20100201_194150a3-7492-4d7d-84e2-5b4297000eae.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5ORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5ORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RORAL GEL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]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 7 of 55 · 1,092 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coleman Sting and Bite ReliefEXTERNAL ANALGESIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4f94ab35-3099-716c-e063-6294a90a8bea2026-04-16WarningsExact identifier
unii: U3RSY48JW5
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
unii: U3RSY48JW5
Sting Relief SwabBENZOCAINE4 Visions LLC4f76a8c5-fde6-eee0-e063-6394a90a09f82026-04-14WarningsExact identifier
unii: U3RSY48JW5
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
unii: PDC6A3C0OX
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
unii: PDC6A3C0OX
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
unii: PDC6A3C0OX
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: PDC6A3C0OX
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.5eb437c5-a2af-4c0d-b7b9-9ab7d093db852026-04-06WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c3fb6705-c647-4fe6-9aca-29735d01d8ea2026-04-02WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
Benzocaine 20%BENZOCAINE 20%PAI Holdings, LLC dba PAI Pharma7fbce9a5-00dc-4a4a-8709-ab752bdf2f592026-03-25WarningsExact identifier
unii: U3RSY48JW5
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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