FDA.reportPublic FDA data

NDC 61010-8100-01 - Pain Relief

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
61010-8100
Requested NDC
61010-8100-01
Package NDCs from labels
61010-8100-2, 61010-8100-1, 61010-8100-01
Manufacturer
Safetec of America, Inc.
Effective date
2024-02-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
61010-8100-1,-2, Pain ReliefSafetec of America, Inc.2024-02-16HUMAN OTC DRUG LABEL
DiphenRemedy Pack LLC | Safetec of America, Inc | Allegiant Health | LNK International Inc. | Granules India Limited | Ohm Laboratories2022-07-11HUMAN OTC DRUG LABEL
Adventure Medical Kits Dental Medic - Tender CorporationTender Corporation2017-03-16HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-8100-1Pain Relief0.75 g in 1 PACKETLIQUID0.754
61010-8100-1Pain Relief144 in 1 BOXLIQUID1444
61010-8100-2Pain Relief0.5 g in 1 PACKETLIQUID0.54
61010-8100-2Adventure Medical Kits Dental Medic0.5 g in 1 PACKETLIQUID2 g in .5200 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-8100PAIN RELIEF (BENZOCAINE) LIQUID [SAFETEC OF AMERICA, INC.]4Current NDC, Legacy NDC, 3 package rows20240217_de84e598-d047-4fae-b2ed-155a3788bc6f.zip
61010-8100ADVENTURE MEDICAL KITS DENTAL MEDIC (BENZOCAINE) KIT [TENDER CORPORATION]1Current NDC, Legacy NDC20170327_4adc9c0d-9ef2-281b-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzocaineACTIVE INGREDIENTU3RSY48JW5PAIN RELIEF (BENZOCAINE) LIQUID [SAFETEC OF AMERICA, INC.]2
benzocaineACTIVE MOIETYU3RSY48JW5PAIN RELIEF (BENZOCAINE) LIQUID [SAFETEC OF AMERICA, INC.]2
peppermint oilINACTIVE INGREDIENTAV092KU4JHPAIN RELIEF (BENZOCAINE) LIQUID [SAFETEC OF AMERICA, INC.]2
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PPAIN RELIEF (BENZOCAINE) LIQUID [SAFETEC OF AMERICA, INC.]2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQPAIN RELIEF (BENZOCAINE) LIQUID [SAFETEC OF AMERICA, INC.]2
saccharin sodium dihydrateINACTIVE INGREDIENTSB8ZUX40TYPAIN RELIEF (BENZOCAINE) LIQUID [SAFETEC OF AMERICA, INC.]2
sorbic acidINACTIVE INGREDIENTX045WJ989BPAIN RELIEF (BENZOCAINE) LIQUID [SAFETEC OF AMERICA, INC.]2

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 1111 · 22,209 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Tropical FruitCALCIUM CARBONATERARITAN PHARMACEUTICALS INC38c6cece-71a0-40d8-bfc8-2f6467f9239b2026-09-05WarningsExact identifier
application number: M001
unii: H0G9379FGK
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
rxcui: 1012100
unii: F5UM2KM3W7
unii: V13007Z41A
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
rxcui: 1012100
unii: F5UM2KM3W7
unii: V13007Z41A
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
application number: M003
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
application number: M003
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
application number: M003
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
application number: M003
unii: 3K9958V90M
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsExact identifier
unii: 362O9ITL9D
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERARITAN PHARMACEUTICALS INC07a50168-6b05-4c99-9969-7d7f0aa54f302026-09-05WarningsExact identifier
application number: M001
unii: H0G9379FGK
DRx CHOICE Antacid Calcium Regular StrengthCALCIUM CARBONATE 500MGRaritan Pharmaceuticals Inc0c579405-9397-4bf2-8441-e89011b19ec42026-09-05WarningsExact identifier
application number: M001
unii: H0G9379FGK
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation71845bf9-8981-4ca0-a62c-dbef102b1b022026-09-04WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
IBUPROFENIBUPROFENAmazon.com Services LLC90659e83-d989-46a5-9680-3a4f616125112026-09-04WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
application number: M003
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
rxcui: 106258
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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