FDA.reportPublic FDA data

Neosporin Plus Pain Relief

Product NDC
69968-0055
11-digit product format
699680055
Labeler code
69968
Product ID
69968-0055_223ce228-cc0e-5108-e063-6294a90a4aea
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-12-01
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
3.5; 10000; 10 mg/g; [USP'U]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Neosporin Plus Pain Relief
Brand name suffix
First Aid Antibiotic/Pain Relieving
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii057Y626693, 19371312D4, 88AYB867L5
Rxcui1359360

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0055-1Neosporin Plus Pain ReliefFirst Aid Antibiotic/Pain Relieving1 in 1 CARTONCREAM17
69968-0055-1Neosporin Plus Pain ReliefFirst Aid Antibiotic/Pain Relieving28.3 g in 1 TUBECREAM28.37
69968-0055-2Neosporin Plus Pain ReliefFirst Aid Antibiotic/Pain Relieving1 in 1 CARTONCREAM17
69968-0055-2Johnson and Johnson All Purpose First Aid Kit14.2 g in 1 TUBECREAM14.2 g10 mg in 1g7
69968-0055-2Neosporin Plus Pain ReliefFirst Aid Antibiotic/Pain Relieving14.2 g in 1 TUBECREAM14.27
69968-0055-2Johnson and Johnson All Purpose First Aid Kit1 in 1 CARTONCREAM10 mg in 1g7
69968-0055-2Johnson and Johnson First Aid Travel Ready80 CT14.2 g in 1 TUBECREAM14.2 g10 mg in 1g3
69968-0055-2Johnson and Johnson First Aid All Purpose160 CT14.2 g in 1 TUBECREAM14.2 g10 mg in 1g3
69968-0055-2Johnson and Johnson First Aid Travel Ready80 CT1 in 1 CARTONCREAM10 mg in 1g3
69968-0055-2Johnson and Johnson First Aid All Purpose160 CT1 in 1 CARTONCREAM10 mg in 1g3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0055-1GM - Gram69968-00553bd0c333-eec9-4f81-8788-875ee16f75bd12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0055NEOSPORIN PLUS PAIN RELIEF FIRST AID ANTIBIOTIC/PAIN RELIEVING (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 4 package rows20241115_23222e54-d793-4d79-980e-550e32a95742.zip
69968-0055JOHNSON AND JOHNSON ALL PURPOSE FIRST AID KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]6Current NDC, Legacy NDC20241116_5cdb47c5-7951-4279-8a05-0a3199d3dd45.zip
69968-0055JOHNSON AND JOHNSON FIRST AID ALL PURPOSE 160 CT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]2Current NDC, Legacy NDC20241116_f3933330-2550-4a88-e053-2a95a90a3997.zip
69968-0055JOHNSON AND JOHNSON FIRST AID TRAVEL READY 80 CT (ACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]2Current NDC, Legacy NDC20241116_f388f105-48ba-4616-e053-2a95a90a0049.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN23222e54-d793-4d79-980e-550e32a957427
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459Tylenol Extra Strength 500 MG Oral TabletPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD5cdb47c5-7951-4279-8a05-0a3199d3dd457
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBD5cdb47c5-7951-4279-8a05-0a3199d3dd457
198440acetaminophen 500 MG Oral TabletSCD5cdb47c5-7951-4279-8a05-0a3199d3dd457
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD23222e54-d793-4d79-980e-550e32a957427
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD5cdb47c5-7951-4279-8a05-0a3199d3dd457
198440APAP 500 MG Oral TabletSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459APAP 500 MG Oral Tablet [Tylenol]SY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1111764Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY23222e54-d793-4d79-980e-550e32a957427
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY23222e54-d793-4d79-980e-550e32a957427
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY23222e54-d793-4d79-980e-550e32a957427
209459Tylenol 500 MG Oral TabletSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459Tylenol Extra Strength 500 MG Oral TabletSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
198440acetaminophen 500 MG Oral TabletPSNf388f105-48ba-4616-e053-2a95a90a00493
198440acetaminophen 500 MG Oral TabletPSNf3933330-2550-4a88-e053-2a95a90a39973
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSNf388f105-48ba-4616-e053-2a95a90a00493
209459Tylenol Extra Strength 500 MG Oral TabletPSNf388f105-48ba-4616-e053-2a95a90a00493
209459Tylenol Extra Strength 500 MG Oral TabletPSNf3933330-2550-4a88-e053-2a95a90a39973
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDf388f105-48ba-4616-e053-2a95a90a00493
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDf3933330-2550-4a88-e053-2a95a90a39973
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBDf3933330-2550-4a88-e053-2a95a90a39973
198440acetaminophen 500 MG Oral TabletSCDf388f105-48ba-4616-e053-2a95a90a00493
198440acetaminophen 500 MG Oral TabletSCDf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDf388f105-48ba-4616-e053-2a95a90a00493
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDf3933330-2550-4a88-e053-2a95a90a39973
198440APAP 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973
198440APAP 500 MG Oral TabletSYf388f105-48ba-4616-e053-2a95a90a00493
209459APAP 500 MG Oral Tablet [Tylenol]SYf3933330-2550-4a88-e053-2a95a90a39973
209459APAP 500 MG Oral Tablet [Tylenol]SYf388f105-48ba-4616-e053-2a95a90a00493
1111764Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSYf388f105-48ba-4616-e053-2a95a90a00493
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSYf388f105-48ba-4616-e053-2a95a90a00493
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSYf388f105-48ba-4616-e053-2a95a90a00493
209459Tylenol 500 MG Oral TabletSYf388f105-48ba-4616-e053-2a95a90a00493
209459Tylenol 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973
209459Tylenol Extra Strength 500 MG Oral TabletSYf388f105-48ba-4616-e053-2a95a90a00493
209459Tylenol Extra Strength 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0055-1699680055011 TUBE in 1 CARTON (69968-0055-1) / 28.3 g in 1 TUBE1 tube2009-12-010000-00-00NoNoCurrent
69968-0055-2699680055021 TUBE in 1 CARTON (69968-0055-2) / 14.2 g in 1 TUBE1 tube2009-12-010000-00-00NoNoCurrent