FDA.reportPublic FDA data

glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum

Product NDC
11673-572
11-digit product format
116730572
Labeler code
11673
Product ID
11673-572_dc36f647-2d3c-442b-b16d-7c0ac65414c6
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum
Dosage form
CREAM
Route
RECTAL; TOPICAL
Labeler
Target Corporation
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-04-01
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
E
Listing certified through
2017-12-31
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
11673-572-242019-10-21C16284748780-1956f9ecf-c1fb-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-572-24glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum1 in 1 BOXCREAM11
11673-572-24glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum51 g in 1 TUBE, WITH APPLICATORCREAM511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-572-24GM - Gram11673-572067dce91-f2b8-4210-a69b-2284a42512b612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
GLYCERINACTIVE MOIETYPDC6A3C0OXGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PETROLATUMACTIVE MOIETY4T6H12BN9UGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PRAMOXINEACTIVE MOIETY068X84E056GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
LAURETH-23INACTIVE INGREDIENTN72LMW566GGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-572GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE, WHITE PETROLATUM CREAM [TARGET CORPORATION]1Legacy NDC, 2 package rows20100202_0dea93da-f123-4b01-b821-85ea3cd61423.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 CreamPSN0dea93da-f123-4b01-b821-85ea3cd614231
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD0dea93da-f123-4b01-b821-85ea3cd614231
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY0dea93da-f123-4b01-b821-85ea3cd614231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11673-572-24116730572241 in 1 BOXHistorical