TheraPlus

Product NDC
55621-005
11-digit product format
556210005
Labeler code
55621
Product ID
55621-005_0884a753-f425-506b-e063-6394a90ac93e
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCI
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-01
Substance
PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM
Active strength
.25; 14; 74.9 g/100g; 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
TheraPlus
Brand name suffix
Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g
MINERAL OIL14 g/100g
PETROLATUM74.9 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1372298Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
edf9f8d5-f55d-4c31-adfb-ba77ca24cc3dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-005-01TheraPlus Plus42 g in 1 TUBEOINTMENT425

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
MINERAL OILACTIVE MOIETYT5L8T28FGPTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PETROLATUMACTIVE MOIETY4T6H12BN9UTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
LAURETH-23INACTIVE INGREDIENTN72LMW566GTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VTHERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-005THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]5Current NDC, Legacy NDC, 1 package rows20231025_edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d.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 4 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
application number: M015
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.53f11395-f460-943f-e063-6294a90affef2026-06-10WarningsExact identifier
application number: M015
Terramed Just Think Comfort Hemorrhoidal WipesLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDERida LLCf6ad00e7-c7b8-40b8-80c2-6e6bf85098b32026-06-08WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELCVS Pharmacy, Inc.50f920da-b41a-480d-b3a0-df940caaee2d2026-06-08Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd5356cf53-935d-a02f-e063-6394a90a6e5a2026-06-05WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
application number: M015
Healcome Lidocaine Numbing CreamLIDOCAINEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD9b4eac02-1b1f-4630-92b4-b1d8c21abab52026-05-29WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomileTOLNAFTATERida LLC5517c43f-03b2-499a-a217-d9cba3fb9fd22026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash CitrusTOLNAFTATERida LLCb4c5da66-5928-4352-ab90-fd46039e79552026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort GynoCare BV Guard Intimate WipesPRAMOXINE HYDROCHLORIDERida LLCbb29f156-37b8-400e-802b-3e2671cb7dc82026-05-27WarningsExact identifier
application number: M015
myDerm MEDICAL NEW Soothing HemorrhoidalWITCH HAZEL PENYLEPHRINE LIDOCAINEInspec Solutions2ff42501-7730-42de-99dd-6fc53bbdf25f2026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool MentholTOLNAFTATERida LLC8b15cb3b-f7cb-4a80-94b2-eeeafc9794e82026-05-27WarningsExact identifier
application number: M015
Lidocaine Roll-onLIDOCAINEYYBA Corp52d060df-2095-dd68-e063-6394a90a77402026-05-27WarningsExact identifier
application number: M015
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) CreamLIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAMJiangxi Yudexi Pharmaceutical Co., LTD52a25b97-7721-6410-e063-6394a90a228f2026-05-25WarningsExact identifier
application number: M015
Arlun LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5241c26b-6c91-65a5-e063-6394a90a24772026-05-20WarningsExact identifier
application number: M015
tuiwaro LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5223b7fe-6aba-c77b-e063-6394a90ad27b2026-05-18WarningsExact identifier
application number: M015
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
application number: M015
OxifyLIDOCAINE 5%Weeks & Leo Compnay, INC.51cd58f7-c1c9-f4e2-e063-6294a90ad9702026-05-14WarningsExact identifier
application number: M015
Lidocaine anorectal creamLIDOCAINE 5%EveryMarket Inc1604daec-812f-4684-ba98-fbcda07a74612026-05-12WarningsExact identifier
application number: M015
PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPESWITCH HAZELHaleon US Holdings LLC485437a8-b2e9-4acf-a20e-edb1f08a9cae2026-05-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSNedf9f8d5-f55d-4c31-adfb-ba77ca24cc3d5
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCDedf9f8d5-f55d-4c31-adfb-ba77ca24cc3d5
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSYedf9f8d5-f55d-4c31-adfb-ba77ca24cc3d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55621-005-015562100050142 g in 1 TUBE (55621-005-01) 42 g2013-03-010000-00-00NoNoCurrent