FDA.reportPublic FDA data

Bloop Hemorrhoid Relief Topical

Product NDC
83838-155
11-digit product format
838380155
Labeler code
83838
Product ID
83838-155_0b6419e3-f1c8-bdfe-e063-6294a90a5d92
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Petrolatum, Phenylephrine HCl, Pramoxine HCl
Dosage form
CREAM
Route
TOPICAL
Labeler
Three Nations Corp
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-14
Substance
GLYCERIN; PRAMOXINE HYDROCHLORIDE; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE, (+/-)-
Active strength
14.4; 1; 15; .25 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Bloop Hemorrhoid Relief Topical
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN14.4 g/100g
PRAMOXINE HYDROCHLORIDE1 g/100g
PETROLATUM15 g/100g
PHENYLEPHRINE HYDROCHLORIDE, (+/-)-.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
88AYB867L5Internal UNII lookup
4T6H12BN9UInternal UNII lookup
O2VT86KV7EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293649Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b6419e3-f1c7-bdfe-e063-6294a90a5d92Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83838-155-01Bloop Hemorrhoid Relief Topical28 g in 1 TUBECREAM281
83838-155-01Bloop Hemorrhoid Relief Topical1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83838-155BLOOP HEMORRHOID RELIEF TOPICAL (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [THREE NATIONS CORP]1Current NDC, 2 package rows20231201_0b6419e3-f1c7-bdfe-e063-6294a90a5d92.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
application number: M015
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.53f11395-f460-943f-e063-6294a90affef2026-06-10WarningsExact identifier
application number: M015
Terramed Just Think Comfort Hemorrhoidal WipesLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDERida LLCf6ad00e7-c7b8-40b8-80c2-6e6bf85098b32026-06-08WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELCVS Pharmacy, Inc.50f920da-b41a-480d-b3a0-df940caaee2d2026-06-08Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd5356cf53-935d-a02f-e063-6394a90a6e5a2026-06-05WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
application number: M015
Healcome Lidocaine Numbing CreamLIDOCAINEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD9b4eac02-1b1f-4630-92b4-b1d8c21abab52026-05-29WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomileTOLNAFTATERida LLC5517c43f-03b2-499a-a217-d9cba3fb9fd22026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash CitrusTOLNAFTATERida LLCb4c5da66-5928-4352-ab90-fd46039e79552026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort GynoCare BV Guard Intimate WipesPRAMOXINE HYDROCHLORIDERida LLCbb29f156-37b8-400e-802b-3e2671cb7dc82026-05-27WarningsExact identifier
application number: M015
myDerm MEDICAL NEW Soothing HemorrhoidalWITCH HAZEL PENYLEPHRINE LIDOCAINEInspec Solutions2ff42501-7730-42de-99dd-6fc53bbdf25f2026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool MentholTOLNAFTATERida LLC8b15cb3b-f7cb-4a80-94b2-eeeafc9794e82026-05-27WarningsExact identifier
application number: M015
Lidocaine Roll-onLIDOCAINEYYBA Corp52d060df-2095-dd68-e063-6394a90a77402026-05-27WarningsExact identifier
application number: M015
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) CreamLIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAMJiangxi Yudexi Pharmaceutical Co., LTD52a25b97-7721-6410-e063-6394a90a228f2026-05-25WarningsExact identifier
application number: M015
Arlun LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5241c26b-6c91-65a5-e063-6394a90a24772026-05-20WarningsExact identifier
application number: M015
tuiwaro LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5223b7fe-6aba-c77b-e063-6394a90ad27b2026-05-18WarningsExact identifier
application number: M015
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
application number: M015
OxifyLIDOCAINE 5%Weeks & Leo Compnay, INC.51cd58f7-c1c9-f4e2-e063-6294a90ad9702026-05-14WarningsExact identifier
application number: M015
Lidocaine anorectal creamLIDOCAINE 5%EveryMarket Inc1604daec-812f-4684-ba98-fbcda07a74612026-05-12WarningsExact identifier
application number: M015
PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPESWITCH HAZELHaleon US Holdings LLC485437a8-b2e9-4acf-a20e-edb1f08a9cae2026-05-11WarningsExact identifier
application number: M015

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 CreamPSN0b6419e3-f1c7-bdfe-e063-6294a90a5d921
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD0b6419e3-f1c7-bdfe-e063-6294a90a5d921
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY0b6419e3-f1c7-bdfe-e063-6294a90a5d921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83838-155-01838380155011 TUBE in 1 BOX (83838-155-01) / 28 g in 1 TUBE1 tube2023-11-14NoNoCurrent