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 5 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRMITSUI MEDICAL HAEMORRHOIDPHENYLEPHRINE HCI WITCH HAZELYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED51720221-893b-cade-e063-6394a90adaec2026-05-10WarningsExact identifier
application number: M015
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
application number: M015
Dr. NumbLIDOCAINEShinpharma Inc32ab24b4-dcec-4a09-e054-00144ff88e882026-04-30WarningsExact identifier
application number: M015
Dr. NumbLIDOCAINEShinpharma Incc2c0cb17-401a-4ba2-aa04-64c9b43cd21b2026-04-30WarningsExact identifier
application number: M015
Dr. NumbLIDOCAINEShinpharma Ince840fba4-86ff-9da0-e053-2995a90a221a2026-04-30WarningsExact identifier
application number: M015
FAMILY Wellness MEDICATED HEMORRHOIDAL WIPESWITCH HAZELFamily Dollar Stores, Inc3f6f68c0-787a-48eb-b042-d4df90ea7e032026-04-17WarningsExact identifier
application number: M015
Equaline HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa6ed1987-37ad-4bfd-8cea-f03426953f5a2026-04-16WarningsExact identifier
application number: M015
Verdibliss HEMORRHOID RELIEF OINTMENTSLIDOCAINE, PHENYLEPHRINEGuangdong Quadrant Ecological Technology Co., Ltd.4f1634d5-7667-b354-e063-6394a90a34e72026-04-10WarningsExact identifier
application number: M015
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
application number: M015
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
application number: M015
Walgreens Pain Relief with LidocaineLIDOCAINE, PHENYLEPHRINE HCLWalgreens Co3ce78f2f-0264-f406-e063-6294a90a7e032026-04-01WarningsExact identifier
application number: M015
LidocaineLIDOCAINEYYBA Corp5256a84a-8dac-8fd4-e063-6294a90a616c2026-04-01WarningsExact identifier
application number: M015
HemorrhoidalLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUMWalgreens Co3d213ba8-3cbe-11c4-e063-6394a90ae0162026-03-30WarningsExact identifier
application number: M015
Critic Aid SkinZINC OXIDEColoplast Corpcaaac1f0-437d-4185-8670-9f11b9cefe632026-03-30WarningsExact identifier
application number: M015
CVS Topical Analgesic HemorrhoidalDIBUCAINECVS PHARMACY,INCb9e20531-3444-4955-b1d3-bb112340d2302026-03-27WarningsExact identifier
application number: M015
ndc (product): 51316-207
Walgreens Moisture BarrierWALGREENS MOISTURE BARRIERWalgreens44fc098c-1f5f-bf82-e063-6294a90a14052026-03-25WarningsExact identifier
application number: M015
LidocaineLIDOCAINEYYBA Corp472fe0d1-31a1-fded-e063-6394a90a4a662026-03-25WarningsExact identifier
application number: M015
Hemorrhoid Relief CreamLIDOCAINE 5% ANORECTALALAINA HEALTHCARE PRIVATE LIMITED53b2c3b0-d729-44d6-bc64-a9e1c93518772026-03-23WarningsExact identifier
application number: M015
LIDOCAINELIDOCAINEYYBA Corp4db609cc-f329-62a4-e063-6394a90aefc12026-03-23WarningsExact identifier
application number: M015
Topical Hemorrhoid Relief GelMENTHOL, UNSPECIFIED FORMYantai Aien Biotechnology Co., Ltd.4d6e6667-ab1c-de7c-e063-6294a90a0b9b2026-03-20WarningsExact 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