FDA.reportPublic FDA data

Bacitracin

Product NDC
71335-2731
11-digit product format
713352731
Labeler code
71335
Product ID
71335-2731_4ea76b1b-e604-48a1-b1ed-6baf56e9bee0
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use • in the eyes • over large areas of the body • if you are allergic to any of the ingredients Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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
71335-2731-1Bacitracin144 in 1 CARTONOINTMENT144100
71335-2731-1Bacitracin0.9 g in 1 PACKETOINTMENT0.9100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2731-1EA - Each71335-2731c448c6ca-d08e-4da4-b77f-6e97c878450712025-09-12

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2731-171335273101144 PACKET in 1 CARTON (71335-2731-1) / .9 g in 1 PACKET144 packet2025-07-30NoNoCurrent