FDA.reportPublic FDA data

ProCure Hemorrhoidal

Product NDC
55681-021
11-digit product format
556810021
Labeler code
55681
Product ID
55681-021_37cdd72a-2001-148c-e063-6394a90af289
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, Petrolatum, Phenylephrine HCl
Dosage form
OINTMENT
Route
RECTAL; TOPICAL
Labeler
Twin Med LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-16
Substance
PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL
Active strength
74.9; .25; 14 g/100g; g/100g; g/100g
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

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
ProCure Hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM74.9 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g
MINERAL OIL14 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
04JA59TNSJInternal UNII lookup
T5L8T28FGPInternal 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
37a4cc43-0d53-f1bf-e063-6394a90a2dc9Available on FDA.report

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
55681-021-02ProCure Hemorrhoidal56.6 g in 1 TUBE, WITH APPLICATOROINTMENT56.62

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 9 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger CotsLIDOCAINECVS PHARMACY, INCcaef51a8-76e9-42b3-a160-c54f62b47de12026-01-05WarningsExact identifier
application number: M015
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
application number: M015
HemRid Anorectal CreamLIDOCAINEKKA & Associates LLCdbeb4325-3e85-1147-e053-2995a90a21602025-12-31WarningsExact identifier
application number: M015
ElixirCurozoleCLOTRIMAZOLEELIXIR HEALTHCARE USA, LLC.0c468a9e-d092-4704-b742-92ecd99182092025-12-26WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEGRAXCELL PHARMACEUTICAL, LLC5162baee-0d63-494e-8046-459437b853482025-12-25WarningsExact identifier
application number: M015
HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDESafeway3e6728b6-26e3-4287-8ba6-e27f305cd93b2025-12-20WarningsExact identifier
application number: M015
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC40fde50a-3cc0-4286-9b33-8f3912254c332025-12-18WarningsExact identifier
application number: M015
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
application number: M015
topcare hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLTopco Associates LLC81a3546b-5099-4b9a-b774-b3e79316b2672025-12-13WarningsExact identifier
application number: M015
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
application number: M015
LMX5LIDOCAINEFerndale Laboratories, Inc.34f8ed6b-4a52-4a99-9c1b-254196dc29b02025-12-10WarningsExact identifier
application number: M015
Curist Hemorrhoid ReliefLIDOCAINELittle Pharma, Inc.d609e1b5-81f0-da12-e053-2a95a90aa8472025-12-08WarningsExact identifier
application number: M015
PURAWITCH HAZELMypura.com Limited1523f52f-6a5b-a12d-e063-6294a90a44962025-12-05WarningsExact identifier
application number: M015
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEMarlex Pharmaceuticals, Inc.c24e2dab-cab4-38f4-e053-2995a90aabae2025-12-04WarningsExact identifier
application number: M015
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc7913bd41-a606-4ca6-b69f-2717c2f54b072025-12-01WarningsExact identifier
application number: M015
Dr Butlers Hemorrhoid and Fissure PFLIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25Beyond Health P.A.f526199e-5c9e-7a3c-e053-2a95a90aa98e2025-11-26WarningsExact identifier
application number: M015
Meicated WipeWITCH HAZELDiamond Wipes International, Inc4458c80c-d013-55ba-e063-6394a90a6b392025-11-24WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
application number: M015
Launch MedicalLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC293ef514-44c1-43ac-9a81-c30e34ad39e52025-11-12WarningsExact identifier
application number: M015
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN37a4cc43-0d53-f1bf-e063-6394a90a2dc92
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD37a4cc43-0d53-f1bf-e063-6394a90a2dc92
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY37a4cc43-0d53-f1bf-e063-6394a90a2dc92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55681-021-025568100210256.6 g in 1 TUBE, WITH APPLICATOR (55681-021-02) 56.6 g2025-06-16NoNoCurrent