FDA.reportPublic FDA data

First Aid Antiseptic

Product NDC
0536-1271
11-digit product format
005361271
Labeler code
0536
Product ID
0536-1271_38911ca2-7c18-5096-e063-6394a90a6121
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-03
Substance
POVIDONE-IODINE
Active strength
100 mg/g
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
First Aid Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312563Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2bcb69e-8ffb-23ee-e053-2995a90aee21Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1271-80First Aid Antiseptic28.4 g in 1 TUBEOINTMENT28.44
0536-1271-80First Aid Antiseptic1 in 1 BOXOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1271-80GM - Gram0536-127159377ec8-6c22-4b4e-869f-db52c458416012021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1271FIRST AID ANTISEPTIC (POVIDONE-IODINE) OINTMENT [RUGBY LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20240110_b2bcb69e-8ffb-23ee-e053-2995a90aee21.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 38 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
New Skin BandageBENZETHONIUM CHLORIDEAdvantice Health, LLC60996119-8367-4e22-b6ec-c36490635fa42026-01-28WarningsExact identifier
application number: M003
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation1409c437-ff17-481d-94be-87dd6d463ba92026-01-28WarningsExact identifier
application number: M003
Singular Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCac2b352f-6cb2-4683-bb41-13e8ecb186bf2026-01-27WarningsExact identifier
application number: M003
Singular Wipes fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLC867a25d2-3d2c-4dad-bbe8-84195c03a87d2026-01-27WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4906f079-8c9f-e3b0-e063-6294a90ad0f82026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4912b681-e21a-1ddf-e063-6294a90aa9f42026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491a6d77-8a84-c76d-e063-6394a90ac61f2026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491b55ca-2c7a-0eb7-e063-6394a90a9cb72026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491c4af8-c699-7128-e063-6294a90ae0f92026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491de8ca-07e7-0aa3-e063-6394a90ae36f2026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.492793db-7dc2-8313-e063-6394a90a52bf2026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4928615e-d1a9-72b8-e063-6394a90aa7ed2026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4943e51a-bb8e-745a-e063-6294a90a0a3d2026-01-26WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.49455156-1072-14f5-e063-6294a90abdff2026-01-26WarningsExact identifier
application number: M003
Anti-bacterial Hand WipesANTI-BACTERIAL HAND WIPESJinhua Aidi Daily Chemical Co., Ltd.494b09a4-4982-13bf-e063-6394a90a486f2026-01-26WarningsExact identifier
application number: M003
Homworks Alcohol Wipes MultipurposeETHYL ALCOHOLAcadian Crossing Consumer Products, LLC.c9f0c3b3-5f39-dfa6-e053-2995a90a76442026-01-26WarningsExact identifier
application number: M003
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation87288939-cc34-4437-94ab-dcb997d6acd52026-01-23WarningsExact identifier
application number: M003
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation10454042-ff2e-44ce-b2e2-436cc004897f2026-01-23WarningsExact identifier
application number: M003
Everlit Survival Sting Relief PadISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a0414ea-f862-aa0f-e063-6294a90aecb72026-01-23WarningsExact identifier
application number: M003
MedlinePOVIDONE-IODINEMedline Industries, LP48ebfdd6-d346-7e26-e063-6394a90af11a2026-01-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312563povidone-iodine 10 % Topical OintmentPSNb2bcb69e-8ffb-23ee-e053-2995a90aee214
312563povidone-iodine 0.1 MG/MG Topical OintmentSCDb2bcb69e-8ffb-23ee-e053-2995a90aee214
312563povidone-iodine 10 % (equal to 1 % available iodine) Topical OintmentSYb2bcb69e-8ffb-23ee-e053-2995a90aee214
312563povidone-iodine 10 % Topical OintmentSYb2bcb69e-8ffb-23ee-e053-2995a90aee214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1271-80005361271801 TUBE in 1 BOX (0536-1271-80) / 28.4 g in 1 TUBE1 tube2020-11-030000-00-00NoNoCurrent