FDA.reportPublic FDA data

Dr. Butler Hemorrhoid Treatment

Product NDC
70942-135
11-digit product format
709420135
Labeler code
70942
Product ID
70942-135_3a88f149-6a81-a6a1-e063-6394a90a0043
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride 0.25%, Witch Hazel 50%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Beyond Health P.A.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-10
Substance
WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE
Active strength
50; .25 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
Dr. Butler Hemorrhoid Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL50 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
101I4J0U34Internal 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
1599785Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2d1c81c-6443-c4b7-e053-2995a90a14d7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70942-135-03Dr. Butler Hemorrhoid Treatment1 in 1 CARTONSPRAY14
70942-135-03Dr. Butler Hemorrhoid Treatment85 g in 1 CANSPRAY854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70942-135DR. BUTLER HEMORRHOID TREATMENT (PHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%) SPRAY [BEYOND HEALTH P.A.]2Current NDC, Legacy NDC, 2 package rows20241217_d2d1c81c-6443-c4b7-e053-2995a90a14d7.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 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
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
1599785phenylephrine HCl 0.25 % / witch hazel 50 % Rectal SprayPSNd2d1c81c-6443-c4b7-e053-2995a90a14d74
1599785phenylephrine hydrochloride 2.5 MG/ML / witch hazel 500 MG/ML Rectal SpraySCDd2d1c81c-6443-c4b7-e053-2995a90a14d74
1599785phenylephrine hydrochloride 0.25 % / witch hazel 50 % Rectal SpraySYd2d1c81c-6443-c4b7-e053-2995a90a14d74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70942-135-03709420135031 CAN in 1 CARTON (70942-135-03) / 85 g in 1 CAN1 can2021-12-100000-00-00NoNoCurrent