FDA.reportPublic FDA data

equate hemorrhoidal

Product NDC
49035-463
11-digit product format
490350463
Labeler code
49035
Product ID
49035-463_f721d8b6-152e-4a3a-97e8-f161e6d29228
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine HCl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Wal-Mart Stores Inc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-23
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

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
equate hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
512OYT1CRRInternal 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
1438497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
581dd76f-d052-4448-8139-9a2e31891b25Available 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
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
49035-463-62equate hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY15
49035-463-62equate hemorrhoidal24 in 1 CARTONSUPPOSITORY245

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRREQUATE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [WAL-MART STORES INC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJEQUATE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [WAL-MART STORES INC]2
COCOA BUTTERACTIVE MOIETY512OYT1CRREQUATE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [WAL-MART STORES INC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVEQUATE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [WAL-MART STORES INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUATE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [WAL-MART STORES INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUATE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [WAL-MART STORES INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEQUATE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-463EQUATE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [WAL-MART STORES INC]5Current NDC, Legacy NDC, 2 package rows20241019_581dd76f-d052-4448-8139-9a2e31891b25.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 22 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family wellnessMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLFRONT PHARMACEUTICAL PLCcfdd61e3-e12e-491c-b2a8-90fae19e88702023-10-27WarningsExact identifier
application number: M015
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
application number: M015
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
application number: M015
Family WellnessPHENYLEPHRINE HCL, PETROLATUM, MINERALZhejiang Jingwei Pharmaceutical Co., Ltd.bfa195d7-d87f-43b5-bbf1-7ec3a451de052023-10-25WarningsExact identifier
application number: M015
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger CotsLIDOCAINECVS PHARMACY, INC82aa128a-44cd-4907-b0f7-8a31e086d3e62023-10-25WarningsExact identifier
application number: M015
TheraPlus PlusPHENYLEPHRINE HCIZhejiang Jingwei Pharmaceutical Co., Ltd.edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d2023-10-25WarningsExact identifier
application number: M015
Assured Bikini Smooth CreamLIDOCAINEZhejiang Jingwei Pharmaceutical Co., Ltd.fb9ddde3-3f40-467e-8aff-26570144f0fc2023-10-25WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
application number: M015
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
application number: M015
Lidocaine 5%LIDOCAINEApnar Pharma LPceedce20-5723-5a9a-e053-2a95a90a17a12023-10-21WarningsExact identifier
application number: M015
Numquick Topical AnalgesicEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDEUnit Dose, Ltd.3f64cbd3-6745-4397-9767-3adc3b301e0e2023-10-19WarningsExact identifier
application number: M015
Healquick Tattoo BalmPETROLATUMUnit Dose, Ltd.96f92c82-a79a-4d7e-ba0c-5ea67e2b6e862023-10-19WarningsExact identifier
application number: M015
Numpot Topical AnestheticLIDOCAINE, PETROLATUMUnit Dose, Ltd.9143b50b-7d76-4545-aa2e-1bb77ffb44ae2023-10-19WarningsExact identifier
application number: M015
Microcaine Topical AnalgesicLIDOCAINEUnit Dose, Ltd.5e8fa8b5-0524-4201-91e1-83e59a8f04152023-10-19WarningsExact identifier
application number: M015
NumstickPETROLATUM, LIDOCAINEUnit Dose, Ltd.127bbd87-5402-4da2-abf3-dac6367735ec2023-10-18WarningsExact identifier
application number: M015
ADVANCED NUMB Topical AnestheticLIDOCAINE HYDROCHLORIDEUber Scientific, LLC859d1cad-badf-4c42-9b08-daacb3fae8b42023-10-13WarningsExact identifier
application number: M015
Hemorrhoidal Pain Relief with Aloe and VitaminEHEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINENeilMed pharmaceuticals Inc.076b5021-8ba0-0204-e063-6294a90a33372023-10-11WarningsExact identifier
application number: M015
Zensa Numbing GelLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Alera Skin Care Products Inc.065a6eec-3896-0da8-e063-6394a90a849d2023-09-27WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN581dd76f-d052-4448-8139-9a2e31891b255
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD581dd76f-d052-4448-8139-9a2e31891b255
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY581dd76f-d052-4448-8139-9a2e31891b255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-463-624903504636224 BLISTER PACK in 1 CARTON (49035-463-62) / 1 SUPPOSITORY in 1 BLISTER PACK24 blister pack2014-05-230000-00-00NoNoCurrent