FDA.reportPublic FDA data

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 9 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger CotsLIDOCAINECVS PHARMACY, INCcaef51a8-76e9-42b3-a160-c54f62b47de12026-01-05WarningsExact identifier
application number: M015
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
application number: M015
HemRid Anorectal CreamLIDOCAINEKKA & Associates LLCdbeb4325-3e85-1147-e053-2995a90a21602025-12-31WarningsExact identifier
application number: M015
ElixirCurozoleCLOTRIMAZOLEELIXIR HEALTHCARE USA, LLC.0c468a9e-d092-4704-b742-92ecd99182092025-12-26WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEGRAXCELL PHARMACEUTICAL, LLC5162baee-0d63-494e-8046-459437b853482025-12-25WarningsExact identifier
application number: M015
HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDESafeway3e6728b6-26e3-4287-8ba6-e27f305cd93b2025-12-20WarningsExact identifier
application number: M015
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC40fde50a-3cc0-4286-9b33-8f3912254c332025-12-18WarningsExact identifier
application number: M015
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
application number: M015
topcare hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLTopco Associates LLC81a3546b-5099-4b9a-b774-b3e79316b2672025-12-13WarningsExact identifier
application number: M015
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
application number: M015
LMX5LIDOCAINEFerndale Laboratories, Inc.34f8ed6b-4a52-4a99-9c1b-254196dc29b02025-12-10WarningsExact identifier
application number: M015
PURAWITCH HAZELMypura.com Limited1523f52f-6a5b-a12d-e063-6294a90a44962025-12-05WarningsExact identifier
application number: M015
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEMarlex Pharmaceuticals, Inc.c24e2dab-cab4-38f4-e053-2995a90aabae2025-12-04WarningsExact identifier
application number: M015
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc7913bd41-a606-4ca6-b69f-2717c2f54b072025-12-01WarningsExact identifier
application number: M015
Dr Butlers Hemorrhoid and Fissure PFLIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25Beyond Health P.A.f526199e-5c9e-7a3c-e053-2a95a90aa98e2025-11-26WarningsExact identifier
application number: M015
Meicated WipeWITCH HAZELDiamond Wipes International, Inc4458c80c-d013-55ba-e063-6394a90a6b392025-11-24WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
application number: M015
Launch MedicalLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC293ef514-44c1-43ac-9a81-c30e34ad39e52025-11-12WarningsExact identifier
application number: M015
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
application number: M015
Hazel Perineal Healing FoamWITCH HAZELJiangsu Senwo Medical Technology Co., Ltd.314b75cb-affe-a248-e063-6294a90a47b72025-11-07WarningsExact 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