FDA.reportPublic FDA data

bacitracin

Product NDC
37808-536
11-digit product format
378080536
Labeler code
37808
Product ID
37808-536_0f6478b5-70d2-45c1-af6f-3faff9fe9eb9
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
H E B
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-06-15
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
bacitracinBACITRACINH E B0a5eeef0-309b-4edd-a664-3d9c1c74a6e92024-09-23WarningsExact 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
37808-536-64bacitracin28 g in 1 TUBEOINTMENT284
37808-536-64bacitracin1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37808-536-64GM - Gram37808-5362a5767d8-c0b7-4079-b8e1-e9de972a3d5c12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [H E B]1
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [H E B]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPBACITRACIN OINTMENT [H E B]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-536BACITRACIN OINTMENT [H E B]4Current NDC, Legacy NDC, 2 package rows20240925_0a5eeef0-309b-4edd-a664-3d9c1c74a6e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN0a5eeef0-309b-4edd-a664-3d9c1c74a6e94
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD0a5eeef0-309b-4edd-a664-3d9c1c74a6e94
1648110bacitracin 500 UNT per GM Topical OintmentSY0a5eeef0-309b-4edd-a664-3d9c1c74a6e94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-536-64378080536641 TUBE in 1 CARTON (37808-536-64) / 28 g in 1 TUBE1 tube1991-06-150000-00-00NoNoCurrent