FDA.reportPublic FDA data

Bacitracin

Product NDC
45802-060
11-digit product format
458020060
Labeler code
45802
Product ID
45802-060_61d48c5f-c2a3-449a-ab1e-ade132c03a93
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-20
Substance
BACITRACIN
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii58H6RWO52I
Rxcui1648110

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-060-01Bacitracin1 in 1 CARTONOINTMENT17
45802-060-01Bacitracin14 g in 1 TUBEOINTMENT147
45802-060-03Bacitracin28 g in 1 TUBEOINTMENT287
45802-060-03Bacitracin1 in 1 CARTONOINTMENT17
45802-060-70Bacitracin0.9 g in 1 PACKETOINTMENT0.97
45802-060-70Bacitracin144 in 1 CARTONOINTMENT1447

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-060-01GM - Gram45802-06006aaf2b2-93c1-45b8-83d1-e9d23faf8b1712013-02-13
45802-060-03GM - Gram45802-060270467c0-25b0-47a2-ae0b-1ff1182d512812013-02-13
45802-060-70EA - Each45802-060bbfda411-51fd-41a5-b803-0eacf6c81bf812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [PERRIGO NEW YORK INC]2
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [PERRIGO NEW YORK INC]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPBACITRACIN OINTMENT [PERRIGO NEW YORK INC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [PERRIGO NEW YORK INC]2
BACITRACINACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-060BACITRACIN OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 6 package rows20240822_bebbedf6-dd65-47a4-aa3e-ad197b3e05a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN0c081802-429f-468f-9650-293cb7a1ad34100
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD0c081802-429f-468f-9650-293cb7a1ad34100
1648110bacitracin 500 UNT per GM Topical OintmentSY0c081802-429f-468f-9650-293cb7a1ad34100
1648110bacitracin 500 UNT in GM Topical OintmentPSN00747e3a-389c-46bc-b6b9-9b3d1d98dbcf20
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD00747e3a-389c-46bc-b6b9-9b3d1d98dbcf20
1648110bacitracin 500 UNT per GM Topical OintmentSY00747e3a-389c-46bc-b6b9-9b3d1d98dbcf20
1648110bacitracin 500 UNT in GM Topical OintmentPSN64aa660d-2d69-48e8-bd0d-4876815d89ff13
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD64aa660d-2d69-48e8-bd0d-4876815d89ff13
1648110bacitracin 500 UNT per GM Topical OintmentSY64aa660d-2d69-48e8-bd0d-4876815d89ff13
1648110bacitracin 500 UNT in GM Topical OintmentPSNbebbedf6-dd65-47a4-aa3e-ad197b3e05a17
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDbebbedf6-dd65-47a4-aa3e-ad197b3e05a17
1648110bacitracin 500 UNT per GM Topical OintmentSYbebbedf6-dd65-47a4-aa3e-ad197b3e05a17
1648110bacitracin 500 UNT in GM Topical OintmentPSN5b0249c0-c196-4d3c-973f-49bd2d3d4a754
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD5b0249c0-c196-4d3c-973f-49bd2d3d4a754
1648110bacitracin 500 UNT per GM Topical OintmentSY5b0249c0-c196-4d3c-973f-49bd2d3d4a754
1648110bacitracin 500 UNT in GM Topical OintmentPSNc134cfc8-f914-6eb8-e053-2a95a90a3ab01
1648110bacitracin 500 UNT in GM Topical OintmentPSNfea57e0a-c472-4c83-9afd-6765a16600b91
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDc134cfc8-f914-6eb8-e053-2a95a90a3ab01
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDfea57e0a-c472-4c83-9afd-6765a16600b91
1648110bacitracin 500 UNT per GM Topical OintmentSYc134cfc8-f914-6eb8-e053-2a95a90a3ab01
1648110bacitracin 500 UNT per GM Topical OintmentSYfea57e0a-c472-4c83-9afd-6765a16600b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-060-01458020060011 TUBE in 1 CARTON (45802-060-01) / 14 g in 1 TUBE1 tube2011-09-010000-00-00NoNoCurrent
45802-060-03458020060031 TUBE in 1 CARTON (45802-060-03) / 28 g in 1 TUBE1 tube2011-08-050000-00-00NoNoCurrent
45802-060-7045802006070144 PACKET in 1 CARTON (45802-060-70) / .9 g in 1 PACKET144 packet2011-06-200000-00-00NoNoCurrent