Bacitracin

Product NDC
67777-116
11-digit product format
677770116
Labeler code
67777
Product ID
67777-116_275e9fdf-28d0-498a-e063-6294a90a7eea
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-12
Substance
BACITRACIN
Active strength
500 [USP'U]/1000mg
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
BacitracinBACITRACINDynarex Corporation7f8752c7-6839-261d-e053-2991aa0a0c302024-11-20WarningsExact 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 or apply over large areas of the body If you are allergic to any of the ingredients Longer than 1 week unless directed by a doctor Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns 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 [USP'U]/1000mg

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
67777-116-10Bacitracin1728 in 1 CASEOINTMENT172810
67777-116-11Bacitracin144 in 1 BOXOINTMENT14410
67777-116-11Bacitracin900 mg in 1 PACKETOINTMENT90010
67777-116-20Bacitracin72 in 1 CASEOINTMENT7210
67777-116-21Bacitracin14000 mg in 1 TUBEOINTMENT1400010
67777-116-30Bacitracin72 in 1 CASEOINTMENT7210
67777-116-31Bacitracin28400 mg in 1 TUBEOINTMENT2840010
67777-116-31Bacitracin1 in 1 BOXOINTMENT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-116-10EA - Each67777-11681543e57-a59d-40dc-8dee-7b6749b6bcf412023-07-06
67777-116-11EA - Each67777-1161fd8a2da-8c1f-4251-90e6-f8f313e3687212023-07-06
67777-116-20GM - Gram67777-1163b081bc4-8e96-4dc0-a6cd-6b8e76999f7512023-07-06
67777-116-21GM - Gram67777-116d872c710-0600-45d6-a69e-cbd24ac0b2f512023-07-06
67777-116-30GM - Gram67777-116be7113ed-2faa-4520-b558-009c856210dc12023-07-06
67777-116-31GM - Gram67777-116e1d78b49-c513-4871-9bfe-252a4b32455d12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-116BACITRACIN OINTMENT [DYNAREX CORPORATION]10Current NDC, Legacy NDC, 8 package rows20241122_7f8752c7-6839-261d-e053-2991aa0a0c30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN7f8752c7-6839-261d-e053-2991aa0a0c3010
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD7f8752c7-6839-261d-e053-2991aa0a0c3010
1648110bacitracin 500 UNT per GM Topical OintmentSY7f8752c7-6839-261d-e053-2991aa0a0c3010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-116-10677770116101728 BOX in 1 CASE (67777-116-10) / 144 PACKET in 1 BOX (67777-116-11) / 900 mg in 1 PACKET1728 box2016-09-120000-00-00NoNoCurrent
67777-116-1167777011611144 in 1 BOXHistorical
67777-116-206777701162072 TUBE in 1 CASE (67777-116-20) / 14000 mg in 1 TUBE (67777-116-21) 72 tube2016-09-120000-00-00NoNoCurrent
67777-116-216777701162114000 mg in 1 TUBE14000 mgHistorical
67777-116-306777701163072 BOX in 1 CASE (67777-116-30) / 1 TUBE in 1 BOX (67777-116-31) / 28400 mg in 1 TUBE72 box2016-09-120000-00-00NoNoCurrent
67777-116-316777701163128400 mg in 1 TUBE28400 mgHistorical