FDA.reportPublic FDA data

CAREALL Hemorrhoidal

Product NDC
51824-119
11-digit product format
518240119
Labeler code
51824
Product ID
51824-119_561c601f-c2ce-f09c-e063-6294a90adb45
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine hcl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
New World Imports, Inc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-01
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
140; 749; 2.5 mg/g; mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
CAREALL Hemorrhoidal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL140 mg/g
PETROLATUM749 mg/g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1372298Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
561c601f-c2cd-f09c-e063-6294a90adb45Available on FDA.report

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 7 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINESainite Trading Shenzhen Co., Ltd.49fcbe81-34b6-5906-e063-6294a90aa65b2026-02-04WarningsExact identifier
application number: M015
Perineal Cooling Pad LinersFRIDA MOM PERINEAL COOLING PAD LINERSFridababy, LLCe9d33d92-34ee-b639-e053-2a95a90a9f362026-02-04WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSportpharm LLC88e3624d-b8bb-4e65-9250-4c51d2bbed162026-02-03WarningsExact identifier
application number: M015
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
application number: M015
LUBRICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.9d98afbf-11ce-745b-e053-2a95a90abc142026-01-28WarningsExact identifier
application number: M015
foster and thrive hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLStrategic Sourcing Services LLC9da843f2-e88c-432e-b091-a6acf81d856b2026-01-22WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLHyVee Incbf1beca0-cc9b-4100-9db7-77f2d1e5497c2026-01-21WarningsExact identifier
application number: M015
GRANULOTION HemorrhoidalMENTHOL, ZINC OXIDEGL Health, Inc.1a32741c-5e4a-40e5-b15a-8233c5bdb92b2026-01-19WarningsExact identifier
application number: M015
HydroseptineZINC OXIDE, MENTHOLAKRON PHARMA INC5359d92e-641e-4076-9d91-18daee58a30e2026-01-19WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL COOLING GELWalgreens1277d2e8-2a5e-23f5-e063-6294a90a69b02026-01-15WarningsExact identifier
application number: M015
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
application number: M015
MEDPURA Vitamin A and D Vitamin A and DMEDPURA VITAMIN A AND DAkron Pharma Inc.38cc2317-691b-4657-af05-c67623eba7602026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens2dd710ac-ab04-4a24-826f-b5a44d0581682026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreensca98dea5-767d-49a8-887b-d96cad487fc42026-01-14WarningsExact identifier
application number: M015
Walgreens Moisture BarrierMENTHOL, AND ZINC OXIDEWalgreen Companya6db6f13-4e02-47dc-aef6-a804506c3d8b2026-01-14WarningsExact identifier
application number: M015
GNP Hemorrhoidal Maximum StrengthHEMORRHOIDALAmerisourcebergen Drug Corporation24103355-cd72-55b0-e063-6394a90a90ec2026-01-14WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51824-119-025182401190256 g in 1 TUBE (51824-119-02) 56 g2026-08-01NoNoCurrent