tina davies IceJelly Hemorrhoidal

Product NDC
84313-101
11-digit product format
843130101
Labeler code
84313
Product ID
84313-101_90fb3e2a-4b65-4bc1-99fc-4cc505e36a85
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Phenylephrine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
TINA DAVIES PROFESSIONAL LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-11
Substance
LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; .25 g/100mL; g/100mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [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
tina davies IceJelly Hemorrhoidal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE5 g/100mL
PHENYLEPHRINE HYDROCHLORIDE.25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal 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
1314136Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
580559bf-d91f-4bb3-9c9b-b7e2cd0686fdAvailable on FDA.report

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 23 · 441 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84313-101-15843130101151 TUBE in 1 BOX (84313-101-15) / 15 mL in 1 TUBE1 tube2026-07-01NoNoCurrent
84313-101-30843130101301 TUBE in 1 BOX (84313-101-30) / 30 mL in 1 TUBE1 tube2026-06-11NoNoCurrent