FDA.reportPublic FDA data

Pain Relief

Product NDC
61010-8100
11-digit product format
610108100
Labeler code
61010
Product ID
61010-8100_11867852-2084-bc57-e063-6394a90a45da
Type
HUMAN OTC DRUG
Nonproprietary name
benzocaine
Dosage form
LIQUID
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-05-01
Substance
BENZOCAINE
Active strength
200 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248280Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
de84e598-d047-4fae-b2ed-155a3788bc6fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
15bd4439-874a-4934-9954-248e5455d460Product name120260310
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609

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 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

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

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 105 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAdvanced Rx of Tennessee, LLC0b7736df-c7e0-7d00-e063-6294a90aa57e2024-12-31WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAdvanced Rx Pharmacy of Tennessee, LLCf4bfc4a6-06ef-1f76-e053-2995a90a2b8f2024-12-31WarningsExact identifier
application number: M017
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLC01cb19a4-ce22-144d-e063-6294a90a8aa32024-12-31WarningsExact identifier
application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving CreamLIDOCAINE, MENTHOLSato Pharmaceutical Co., Ltd.2251e96b-d050-4ec2-a6b9-6659610885bf2024-12-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESafewayaf2e2ef3-0f3f-4592-8081-b6553ade2f5a2024-12-26WarningsExact identifier
application number: M017
Comforte Menstrual Cramp Relief CreamMENTHOLPMS4PMS LLCc121537e-3333-4f35-8c77-20086158dff42024-12-26WarningsExact identifier
application number: M017
N-Labs Arcticzen Pain Relief KneeCAMPHOR (SYNTHETIC), MENTHOLNUTRIOMO LABS PTE. LTD05ee574a-854c-4a77-be77-082055075c4d2024-12-26WarningsExact identifier
application number: M017
BiteMD External Analgesic First Aid AntisepticBENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOLUnited Industries Corporation4c60db03-6d2b-4ae0-a200-718b3a50eb0f2024-12-23WarningsExact identifier
application number: M017
GNP Anti ItchCAMPHOR, MENTHOLAMERISOURCEBERGEN DRUG CORPORATIONb4f2d6f7-2287-47d8-e053-2995a90ae3352024-12-23WarningsExact identifier
application number: M017
cool and heat pain relieving liquidMENTHOLBionpharma Inc.ec6f59d8-45c5-46a0-e053-2995a90a239f2024-12-23WarningsExact identifier
application number: M017
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact identifier
application number: M017
pain relief roll-onLIDOCAINE 4%Bionpharma Inc.f607b6dc-8d13-604a-e053-2995a90a59ab2024-12-23WarningsExact identifier
application number: M017
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMiramar Cosmetics, Inc DBA Miramar Laba6c4889c-e7a9-44b9-bd9a-70fd6e8c48252024-12-23WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONE 1%Trifecta Pharmaceuticals USA LLCaf5daf6c-bcad-8ebf-e053-2a95a90af1b02024-12-20WarningsExact identifier
application number: M017
Pain Itch ReliefLIDOCAINE HCITrifecta Pharmaceutical USA LLCf40b19a8-795c-f514-e053-2a95a90a6d152024-12-20WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.44d3638d-f29b-0e01-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Rhuli GelCAMPHOR, MENTHOLTrifecta Pharmaceuticals USA, LLC.4fbb3c23-ed47-336e-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONERugby Laboratories132982ea-cce6-687c-e063-6294a90a46322024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLC9bb98452-a605-5c20-e053-2995a90a1ea72024-12-20WarningsExact identifier
application number: M017
DCH Cooling Pain ReliefMENTHOL 10.5%Derma Care Research Labs, LLC00dcdae0-c744-8402-e063-6294a90a12f82024-12-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248280benzocaine 20 % Dental CreamPSNde84e598-d047-4fae-b2ed-155a3788bc6f4
248280benzocaine 200 MG/ML Oral CreamSCDde84e598-d047-4fae-b2ed-155a3788bc6f4
248280benzocaine 20 % Dental CreamSYde84e598-d047-4fae-b2ed-155a3788bc6f4
1367204acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
198440acetaminophen 500 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN5d185f23-8af6-4e36-b514-5662986520a51
248280benzocaine 20 % Dental CreamPSN4adc9c0d-9ef2-281b-e054-00144ff8d46c1
308761bismuth subsalicylate 262 MG Chewable TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 1 % Topical CreamPSN5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG 24HR Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
995666meclizine HCl 25 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1367204acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
198440acetaminophen 500 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD5d185f23-8af6-4e36-b514-5662986520a51
248280benzocaine 200 MG/ML Oral CreamSCD4adc9c0d-9ef2-281b-e054-00144ff8d46c1
308761bismuth subsalicylate 262 MG Chewable TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG Chewable TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
995666meclizine hydrochloride 25 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1367204APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
198440APAP 500 MG Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY5d185f23-8af6-4e36-b514-5662986520a51
248280benzocaine 20 % Dental CreamSY4adc9c0d-9ef2-281b-e054-00144ff8d46c1
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 1 % Topical CreamSY5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG 24 HR Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-8100-161010810001144 PACKET in 1 BOX (61010-8100-1) / .75 g in 1 PACKET144 packet2019-02-010000-00-00NoNoCurrent
61010-8100-261010810002.5 g in 1 PACKET (61010-8100-2) 2019-02-010000-00-00NoNoCurrent