P25 Progesterone Cream

Product NDC
82018-0011
11-digit product format
820180011
Labeler code
82018
Product ID
82018-0011_3791c949-aa9f-0039-e063-6394a90a56ba
Type
HUMAN OTC DRUG
Nonproprietary name
progesterone
Dosage form
CREAM
Route
TRANSDERMAL
Labeler
SHYNE BRANDS
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-06-01
Substance
PROGESTERONE
Active strength
25 mg/85g
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
P25 Progesterone Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE25 mg/85g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82018-0011-52025-06-14C16284748780-1f386c649-f3da-0266-e053-dadaa90a7c1aP25 Progesterone Cream
82018-0011-52023-01-30C16284748780-1f386c649-f3da-0266-e053-dadaa90a7c1aP25 Progesterone Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82018-0011-5P25 Progesterone Cream85 g in 1 BOTTLE, PUMPCREAM854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82018-0011P25 PROGESTERONE CREAM (PROGESTERONE) CREAM [SHYNE BRANDS]3Current NDC, Legacy NDC, 1 package rows20210622_c47169b7-1b6a-2ad0-e053-2995a90a0b19.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82018-0011-58201800110585 g in 1 BOTTLE, PUMP (82018-0011-5) 85 g2025-06-010000-00-00NoNoCurrent