FDA.reportPublic FDA data

QUALITY CHOICE BACITRACIN

Product NDC
63868-960
Requested package NDC
63868-960-28
11-digit product format
638680960
Labeler code
63868
Product ID
63868-960_bcd18b1e-9db6-480b-b374-2fcabe3deed7
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN
Dosage form
OINTMENT
Route
TOPICAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-02-13
Marketing end
0000-00-00
Substance
BACITRACIN
Active strength
500 [USP'U]/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-96063868-960-28IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-960-282022-01-28C16284748780-1d6a99b39-cfca-a426-e053-dadaa90af4c260cacde0-e504-4ad0-8f5d-efa0aad9ba8f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-960-28QUALITY CHOICE BACITRACIN1 in 1 CARTONOINTMENT13
63868-960-28QUALITY CHOICE BACITRACIN28 g in 1 TUBEOINTMENT283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-960-28GM - Gram63868-96089229402-1e30-40e8-8816-12b5cd53402012020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IQUALITY CHOICE BACITRACIN (BACITRACIN) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]2
BACITRACINACTIVE MOIETY58H6RWO52IQUALITY CHOICE BACITRACIN (BACITRACIN) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XQUALITY CHOICE BACITRACIN (BACITRACIN) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPQUALITY CHOICE BACITRACIN (BACITRACIN) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UQUALITY CHOICE BACITRACIN (BACITRACIN) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MQUALITY CHOICE BACITRACIN (BACITRACIN) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-960QUALITY CHOICE BACITRACIN (BACITRACIN) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]3Legacy NDC, 2 package rows20161013_60cacde0-e504-4ad0-8f5d-efa0aad9ba8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN60cacde0-e504-4ad0-8f5d-efa0aad9ba8f3
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD60cacde0-e504-4ad0-8f5d-efa0aad9ba8f3
1648110bacitracin 500 UNT per GM Topical OintmentSY60cacde0-e504-4ad0-8f5d-efa0aad9ba8f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-960-28638680960281 TUBE in 1 CARTON (63868-960-28) > 28 g in 1 TUBE1 tube2016-10-120000-00-00NoNoCurrent