FDA.reportPublic FDA data

topcare hemorrhoidal

Product NDC
36800-279
11-digit product format
368000279
Labeler code
36800
Product ID
36800-279_4b69c540-9dad-4c55-b6e9-8d15dcd6e84c
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine HCl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Topco Associates LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-03
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2211; 6.5 mg/1; mg/1
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
topcare hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCOA BUTTER2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE6.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii512OYT1CRR, 04JA59TNSJ
Rxcui1438497

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
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-279-53topcare hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY18
36800-279-53topcare hemorrhoidal12 in 1 CARTONSUPPOSITORY128
36800-279-62topcare hemorrhoidal24 in 1 CARTONSUPPOSITORY248
36800-279-62topcare hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-279-53EA - Each36800-2799b462efb-0a21-49f2-a245-6eb734e321c112016-04-04
36800-279-62EA - Each36800-279b11610e3-ff9d-4e7b-af32-4315b4ebf59712016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRTOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]2
COCOA BUTTERACTIVE MOIETY512OYT1CRRTOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-279TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 4 package rows20241024_81a3546b-5099-4b9a-b774-b3e79316b267.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN81a3546b-5099-4b9a-b774-b3e79316b2678
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD81a3546b-5099-4b9a-b774-b3e79316b2678
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY81a3546b-5099-4b9a-b774-b3e79316b2678

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-279-533680002795312 BLISTER PACK in 1 CARTON (36800-279-53) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2014-11-030000-00-00NoNoCurrent
36800-279-623680002796224 BLISTER PACK in 1 CARTON (36800-279-62) > 1 SUPPOSITORY in 1 BLISTER PACK24 blister pack2014-11-030000-00-00NoNoCurrent