FDA.reportPublic FDA data

CVS Topical Analgesic Hemorrhoidal

Product NDC
51316-207
11-digit product format
513160207
Labeler code
51316
Product ID
51316-207_4e0916a9-7c93-eb70-e063-6294a90a11b6
Type
HUMAN OTC DRUG
Nonproprietary name
DIBUCAINE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
CVS PHARMACY,INC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-14
Substance
DIBUCAINE
Active strength
10 mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [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
CVS Topical Analgesic Hemorrhoidal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIBUCAINE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L6JW2TJG99Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9e20531-3444-4955-b1d3-bb112340d230Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-207-28CVS Topical Analgesic Hemorrhoidal28 mL in 1 TUBEOINTMENT281

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
238784dibucaine 1 % Rectal OintmentPSNb9e20531-3444-4955-b1d3-bb112340d2301
238784dibucaine 0.01 MG/MG Rectal OintmentSCDb9e20531-3444-4955-b1d3-bb112340d2301
238784dibucaine 1 % Rectal OintmentSYb9e20531-3444-4955-b1d3-bb112340d2301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-207-285131602072828 mL in 1 TUBE (51316-207-28) 28 ml2026-02-14NoNoCurrent