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
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
14; 74.9; .25 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

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
MINERAL OIL14 g/100g
PETROLATUM74.9 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP, 4T6H12BN9U, 04JA59TNSJ
Rxcui1372298

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

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