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 1 of 1089 · 21,768 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2026-10-23WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Topcare Maximum StrengthBENZOCAINETopco Associates LLC6586fcda-b232-46b4-8461-c0042a4127c62026-10-06WarningsExact identifier
unii: U3RSY48JW5
Meijer Adult Mucus Plus chest congestionGUAIFENESINMEIJER DISTRIBUTION, INCf6a23be6-0313-4c23-afb7-576666b80e212026-10-05WarningsExact identifier
application number: M012
unii: 495W7451VQ
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302026-10-01WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Wet Ones Hand Sanitizer Mist Lavender BlossomETHYL ALCOHOLEdgewell Personal Care Brands LLCdae52e15-9161-c8d2-e053-2a95a90adb982026-09-29WarningsExact identifier
unii: 3K9958V90M
childrens allergy reliefLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbc789b82-56ca-4248-b60a-252d9695636a2026-09-29WarningsExact identifier
unii: 7AJO3BO7QN
Pharmacys Prescription 4.5 OZ Creamy Petroleum JellyWHITE PETROLATUMAmerican Consumer Products Corp.5c3eb6b1-d570-0b4c-e063-6394a90af4622026-09-24WarningsExact identifier
unii: 4T6H12BN9U
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Dramamine OrangeDIMENHYDRINATEMedtech Products Inc.76166156-bce1-492f-833e-6bbd07859c3f2026-09-17WarningsExact identifier
application number: M009
SOUR LEMON HAND SANITIZER Pink Guava SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO0adfe188-4613-47dc-a9a3-5c9cfca781a82026-09-17WarningsExact identifier
unii: 3K9958V90M
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
hand sanitizer chocolate chip cookie scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO69d423f2-ff9f-48e0-a553-c7f4aaf37b292026-09-17WarningsExact identifier
unii: 3K9958V90M
12 hr relief cough dmDEXTROMETHORPHAN POLISTIREXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED03c44e2f-d6e3-4c78-9c9a-92d1708a62fe2026-09-16WarningsExact identifier
unii: 9D2RTI9KYH
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Pepto Nausea Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY29a1bd1e-d0e0-478f-e063-6394a90ab0aa2026-09-10WarningsExact identifier
application number: M009
rxcui: 995666
unii: HDP7W44CIO
Medique Diotame InstydoseBISMUTH SUBSALICYLATEUnifirst First Aid Corporation5b214128-6980-0f84-e063-6294a90ad8ca2026-09-10WarningsExact identifier
application number: M008
unii: 62TEY51RR1
daytime nighttime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationeb58871d-f351-47a1-aeab-254ec6693ddd2026-09-10WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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