FDA.reportPublic FDA data

Walgreens Maximum Strength Hemorrhoidal

Product NDC
0363-1760
11-digit product format
003631760
Labeler code
0363
Product ID
0363-1760_7c793b62-7cde-7e23-e053-2a91aa0a435e
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Phenylephrine HCL, Pramoxine HCL, and White petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Walgreen Company
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-02-25
Marketing end
0000-00-00
Substance
GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM
Active strength
0 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-1760-262022-01-28C16284748780-1d6a99b39-9dd1-a426-e053-dadaa90af4c2Walgreens Hemorrhoidal Cream 0.9OZ (with applicator) 902035 (2018)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1760-26Walgreens Maximum Strength Hemorrhoidal26 g in 1 TUBECREAM264
0363-1760-26Walgreens Maximum Strength Hemorrhoidal1 in 1 BOXCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5WALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
GLYCERINACTIVE MOIETYPDC6A3C0OXWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
PETROLATUMACTIVE MOIETY4T6H12BN9UWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
PRAMOXINEACTIVE MOIETY068X84E056WALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
LANOLININACTIVE INGREDIENT7EV65EAW6HWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3WALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RWALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1760WALGREENS MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, AND WHITE PETROLATUM) CREAM [WALGREEN COMPANY]4Legacy NDC, 2 package rows20181208_9191522e-f1d3-4922-8710-9827f78a823d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN9191522e-f1d3-4922-8710-9827f78a823d4
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD9191522e-f1d3-4922-8710-9827f78a823d4
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY9191522e-f1d3-4922-8710-9827f78a823d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1760-26003631760261 TUBE in 1 BOX (0363-1760-26) > 26 g in 1 TUBE1 tube2016-11-080000-00-00NoNoCurrent