FDA.reportPublic FDA data

HEMORRHOIDALCREAMPROCURE

Product NDC
55681-410
11-digit product format
556810410
Labeler code
55681
Product ID
55681-410_0e71885d-e860-73f9-e063-6294a90a1213
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl, Petrolatum, Mineral Oil
Dosage form
CREAM
Route
TOPICAL
Labeler
TWIN MED, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-05
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
14; 74.9; .25 g/100g; g/100g; g/100g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HEMORRHOIDALCREAMPROCURE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL14 g/100g
PETROLATUM74.9 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP, 4T6H12BN9U, 04JA59TNSJ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-410-55HEMORRHOIDALCREAMPROCURE56.6 g in 1 TUBECREAM56.64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-410HEMORRHOIDALCREAMPROCURE (PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL) CREAM [TWIN MED, LLC]4Current NDC, Legacy NDC, 1 package rows20240109_e9c44756-1c98-41be-e053-2995a90a35b4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55681-410-555568104105556.6 g in 1 TUBE (55681-410-55) 56.6 g2022-10-050000-00-00NoNoCurrent