FDA.reportPublic FDA data

BioDCream

Product NDC
45737-701
11-digit product format
457370701
Labeler code
45737
Product ID
45737-701_56418335-c450-468d-8ff1-37747778a7f6
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Advanced Generic Corporation
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-04-01
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
15 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45737-701IInactivated by FDA2026-08-17
excluded packagepackage45737-70145737-701-04IInactivated by FDA2026-08-17

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage45737-701-04e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-701-049bebd1f3094a…5416666fcb17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-701-042020-12-23C16284748780-19d75b9d0-81bb-f424-e053-dadaa90a57ceAGC-BioDCream 701
45737-701-042020-01-31C16284748780-19d75b9d0-81bb-f424-e053-dadaa90a57ceAGC-BioDCream 701

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-701-04BioDCream125 g in 1 JARCREAM1257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-701-04GM - Gram45737-70157c7d751-74b8-4c0a-8463-0e1997f521c912025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-701BIODCREAM (ZINC OXIDE) CREAM [ADVANCED GENERIC CORPORATION]7Legacy NDC, 1 package rows20241222_89a3a755-0928-471b-95ed-8b07d08e4675.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793915zinc oxide 15.25 % Topical CreamPSN89a3a755-0928-471b-95ed-8b07d08e46757
1793915zinc oxide 153 MG/ML Topical CreamSCD89a3a755-0928-471b-95ed-8b07d08e46757
1793915zinc oxide 15.25 % Topical CreamSY89a3a755-0928-471b-95ed-8b07d08e46757
1793915ZNO 153 MG/ML Topical CreamSY89a3a755-0928-471b-95ed-8b07d08e46757

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-701-0445737070104125 g in 1 JAR (45737-701-04) 125 g2016-04-010000-00-00NoNoCurrent