FDA.reportPublic FDA data

Bacitracin

Product NDC
87236-000
11-digit product format
872360000
Labeler code
87236
Product ID
87236-000_5100b467-4cc4-a162-e063-6394a90acfee
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
AlderMed Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
Substance
BACITRACIN
Active strength
500 [iU]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [iU]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii58H6RWO52I

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
87236-000-01Bacitracin1 in 1 CARTONOINTMENT15
87236-000-01Bacitracin28.4 g in 1 TUBEOINTMENT28.45
87236-000-02Bacitracin0.9 g in 1 PACKETOINTMENT0.95
87236-000-09Bacitracin1 in 1 CARTONOINTMENT15
87236-000-09Bacitracin0.9 g in 1 PACKETOINTMENT0.95
87236-000-14Bacitracin14.2 g in 1 TUBEOINTMENT14.25
87236-000-14Bacitracin1 in 1 CARTONOINTMENT15
87236-000-44Bacitracin144 in 1 CARTONOINTMENT1445
87236-000-44Bacitracin0.9 g in 1 PACKETOINTMENT0.95

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN3f0eb4a0-f7bf-45f7-8885-92c65a4bd8995
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD3f0eb4a0-f7bf-45f7-8885-92c65a4bd8995
1648110bacitracin 500 UNT per GM Topical OintmentSY3f0eb4a0-f7bf-45f7-8885-92c65a4bd8995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87236-000-01872360000011 TUBE in 1 CARTON (87236-000-01) / 28.4 g in 1 TUBE1 tube2025-11-01NoNoCurrent
87236-000-0287236000002.9 g in 1 PACKET (87236-000-02) 2025-11-01NoNoCurrent
87236-000-09872360000091 in 1 CARTONHistorical
87236-000-14872360000141 TUBE in 1 CARTON (87236-000-14) / 14.2 g in 1 TUBE1 tube2025-11-01NoNoCurrent
87236-000-4487236000044144 PACKET in 1 CARTON (87236-000-44) / .9 g in 1 PACKET144 packet2025-11-01NoNoCurrent