FDA.reportPublic FDA data

HemorrhoidalOintment

Product NDC
69396-082
11-digit product format
693960082
Labeler code
69396
Product ID
69396-082_298dbfb6-2046-47a1-e063-6294a90a5985
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, Petrolatum, Phenylephrine HCI
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-18
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
14; 74.9; .25 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
HemorrhoidalOintment
Listing expiration
2026-12-31

Active Ingredients#

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

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
c50cc6ad-e8a0-47c1-e053-2a95a90a4de6Available 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
69396-082-02HemorrhoidalOintment57 g in 1 TUBEOINTMENT573
69396-082-02HemorrhoidalOintment1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-082HEMORRHOIDALOINTMENT (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]3Current NDC, Legacy NDC, 2 package rows20241220_c50cc6ad-e8a0-47c1-e053-2a95a90a4de6.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 15 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BODY ACTION PRODUCTS Anal Glide ExtraBENZOCAINEPRODUCT MAX GROUP INC282ac8d3-2caf-42de-b347-450e9c7a9e502025-04-03WarningsExact identifier
application number: M015
Numb 520LIDOCAINEClinical Resolution Laboratory, Inc.984c4bee-0d44-4e0f-a057-0d54400c4cac2025-04-02WarningsExact identifier
application number: M015
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
application number: M015
HemAwayLIDOCAINEMelaleuca, Inc.cf842adf-fcd7-2c8c-e053-2995a90adea62025-03-27WarningsExact identifier
application number: M015
Numb and Number Anorectal CreamLIDOCAINEDermtech Labs, Inc31420635-5021-173d-e063-6294a90a407a2025-03-26WarningsExact identifier
application number: M015
Leader Maximum Strength Hemorrhoidal ReliefLIDOCAINECardinal Health,Inc.65c780b0-7f47-4ae9-a847-c22deaaa28882025-03-21WarningsExact identifier
application number: M015
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
application number: M015
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
application number: M015
Numbskin Maximum Strength Pain RelieverLIDOCAINEShinpharma Inc2f288bde-99fd-42f8-e063-6394a90a0f052025-02-27WarningsExact identifier
application number: M015
PREPARATION H TOTABLES IRRITATION RELIEF WIPESWITCH HAZELHaleon US Holdings LLC1953ec64-20ce-488b-8f14-44e15cc9e7202025-02-21WarningsExact identifier
application number: M015
LBRI STOP THE PAIN Super Aloe Pain Relief CreamMENTHOL, METHYL SALICYLATEL'BRI HEALTH AND BEAUTY INC62e18a37-c0db-4b1e-a6a1-35684cc00e082025-01-28WarningsExact identifier
application number: M015
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
application number: M015
lidocaineLIDOCAINENivagen Pharmaceuticals, Inc.32964ec3-1880-477b-9f71-2222c39106aa2025-01-23WarningsExact identifier
application number: M015
Hemorrhoidal cocoa butterHEMORRHOIDALNeilMed Pharmaceuticals Inc.03b159b0-b960-b38d-e063-6394a90a94622025-01-17WarningsExact identifier
application number: M015
Gentle Laxative BisacodylGENTLE LAXATIVE BISACODYLNeilMed Pharmaceuticals Inc03b3733a-4d78-149f-e063-6294a90a65182025-01-17WarningsExact identifier
application number: M015
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
application number: M015
Pre-moistened Medicated Wipes, Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent, Walgreens Pre-moistened Medicated Wipes, Walgreens Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal AstringentWITCH HAZELWalgreens Company209a111b-d169-cb5d-e063-6394a90a33ca2025-01-15WarningsExact identifier
application number: M015
Pre-moistened Medicated Pads, Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel, Walgreens Pre-moistened Medicated Pads, Walgreens Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch HazelWITCH HAZELWalgreens Company1e2dcec1-a1fe-71d2-e063-6394a90a99082025-01-15WarningsExact identifier
application number: M015
AER Pre-moistened Witch Hazel PadWITCH HAZELBirchwood Laboratories LLC1cca622f-0a6b-4f35-9355-34c249ee705e2025-01-14WarningsExact identifier
application number: M015
B-SURE Traveler ToweletteB-SURE TRAVELERBirchwood Laboratories LLCe1a5da94-6a1a-497b-a737-1c1541bf04042025-01-14WarningsExact 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 OintmentPSNc50cc6ad-e8a0-47c1-e053-2a95a90a4de63
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCDc50cc6ad-e8a0-47c1-e053-2a95a90a4de63
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSYc50cc6ad-e8a0-47c1-e053-2a95a90a4de63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-082-02693960082021 TUBE in 1 BOX (69396-082-02) / 57 g in 1 TUBE1 tube2021-06-180000-00-00NoNoCurrent