Molecular AF Molecular Cream

Product NDC
76348-402
Requested package NDC
76348-402-02
11-digit product format
763480402
Labeler code
76348
Product ID
76348-402_d5c9e15b-7e83-d9a5-e053-2995a90a9725
Type
HUMAN OTC DRUG
Nonproprietary name
Molecular AF Molecular Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Renu Laboratories, Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-31
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
0 g/14g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage76348-40276348-402-02IInactivated 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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-402-022025-01-30C16284748780-12cef2736-8e5a-d83d-e063-dadaa90ab31fMolecular AF Molecular Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-402-01Molecular AF Molecular Cream14 g in 1 TUBECREAM1414
76348-402-02Molecular AF Molecular Cream1 in 1 BOXCREAM114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
MiconazoleACTIVE MOIETY7NNO0D7S5MMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0MOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
Cinnamon OilINACTIVE INGREDIENTE5GY4I6YCZMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
Ethyl MacadamiateINACTIVE INGREDIENTANA2NCS6V1MOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
Olive OilINACTIVE INGREDIENT6UYK2W1W1EMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
Oregano Leaf OilINACTIVE INGREDIENT7D0CGR40U1MOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
POLAWAX POLYSORBATEINACTIVE INGREDIENTQ504PL8E0VMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3MOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
Tea Tree OilINACTIVE INGREDIENTVIF565UC2GMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
TRIMETHYL-1,3-PENTANEDIOLINACTIVE INGREDIENTWT1X081P0LMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
WaterINACTIVE INGREDIENT059QF0KO0RMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEMOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-402MOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]14Legacy NDC, 2 package rows20220118_0fdc69e0-bb02-5de4-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN0fdc69e0-bb02-5de4-e054-00144ff8d46c14
998483miconazole nitrate 20 MG/ML Topical CreamSCD0fdc69e0-bb02-5de4-e054-00144ff8d46c14
998483miconazole nitrate 2 % Topical CreamSY0fdc69e0-bb02-5de4-e054-00144ff8d46c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76348-402-02763480402021 TUBE in 1 BOX (76348-402-02) > 14 g in 1 TUBE (76348-402-01) 1 tube2015-03-310000-00-00NoNoCurrent