FDA.reportPublic FDA data

P50 Progesterone Cream

Product NDC
82018-0012
11-digit product format
820180012
Labeler code
82018
Product ID
82018-0012_3792493b-80b7-2a3e-e063-6394a90aed7c
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
1 mg/mg
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
P50 Progesterone CreamPROGESTERONESHYNE BRANDSc47121df-6c04-b273-e053-2a95a90aa5492025-06-01WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNING: FOR EXTERNAL COSMETIC USE ONLY. Discontinue use if irritation or red skin develops, and consult a Physician. If pregnant, nursing, or if you have a serious medical condition consult a healthcare professional before using this product. Do not use with any other progesterone or progestins. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement: This product contains progesterone, a chemical known only to the State of California to cause cancer. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. KEEP OUT OF REACH OF CHILDREN.

Additional Listing Data#

Finished product
Yes
Brand name base
P50 Progesterone Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE1 mg/mg

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
82018-0012-62025-06-14C16284748780-1f386c649-dbe6-0266-e053-dadaa90a7c1aP50 Progesterone Cream
82018-0012-62023-01-30C16284748780-1f386c649-dbe6-0266-e053-dadaa90a7c1aP50 Progesterone Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82018-0012-6P50 Progesterone Cream85000 mg in 1 BOTTLE, PUMPCREAM850004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82018-0012P50 PROGESTERONE CREAM (PROGESTERONE) CREAM [SHYNE BRANDS]3Current NDC, Legacy NDC, 1 package rows20210622_c47121df-6c04-b273-e053-2a95a90aa549.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82018-0012-68201800120685000 mg in 1 BOTTLE, PUMP (82018-0012-6) 85000 mg2025-06-010000-00-00NoNoCurrent