Bacitracin

Product NDC
63187-299
11-digit product format
631870299
Labeler code
63187
Product ID
63187-299_41cd2973-b1b3-4201-bbdb-f5a113cdb59d
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Proficient Rx LP
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-12-01
Substance
BACITRACIN
Active strength
500 [iU]/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
BacitracinBACITRACINProficient Rx LPe1166948-5d80-44c2-a20d-78be631647d92024-01-01WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings: For external use only Dosage and Administration: • clean the affected areas • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily • may be covered with a sterile bandage Stop use and ask a doctor if • the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use: • if you are allergic to any of the ingredients • in the eyes • over large areas of the body • longer than 1 week unless directed by a doctor Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [iU]/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
63187-299-01Bacitracin28.35 g in 1 TUBEOINTMENT28.355

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [PROFICIENT RX LP]1
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [PROFICIENT RX LP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBACITRACIN OINTMENT [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-299BACITRACIN OINTMENT [PROFICIENT RX LP]5Current NDC, Legacy NDC, 1 package rows20240123_e1166948-5d80-44c2-a20d-78be631647d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSNe1166948-5d80-44c2-a20d-78be631647d95
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDe1166948-5d80-44c2-a20d-78be631647d95
1648110bacitracin 500 UNT per GM Topical OintmentSYe1166948-5d80-44c2-a20d-78be631647d95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-299-016318702990128.35 g in 1 TUBE (63187-299-01) 28.35 g2019-01-010000-00-00NoNoCurrent