FDA.reportPublic FDA data

PRAX

Product NDC
0496-0748
11-digit product format
004960748
Labeler code
0496
Product ID
0496-0748_297a2f2f-8355-6e34-e063-6394a90add60
Type
HUMAN OTC DRUG
Nonproprietary name
pramoxine hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Ferndale Laboratories, Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-01
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
10 mg/mL
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
PRAX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246075Internal RxNorm lookup
1246076Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
674f0d8b-3d50-42b1-8401-d2967bcdf5cfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0496-0748-03PRAX237 mL in 1 BOTTLELOTION2373
0496-0748-04PRAX118 mL in 1 BOTTLELOTION1183
0496-0748-15PRAX15 mL in 1 BOTTLELOTION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0496-0748-03ML - Milliliter0496-0748b6504dad-0912-4d55-9453-e5d6c6a530c012013-07-02
0496-0748-04ML - Milliliter0496-0748b54a913e-a7ae-4fa8-ac21-94664fed7c1b12013-07-02
0496-0748-15ML - Milliliter0496-074804165e3a-56fa-4666-879e-9ba45270066812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
PRAMOXINEACTIVE MOIETY068X84E056PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72XPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OMPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5APRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0748PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]3Current NDC, Legacy NDC, 3 package rows20241219_674f0d8b-3d50-42b1-8401-d2967bcdf5cf.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 20 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preparation H Cooling GelPHENYLEPHRINE HCL, WITCH HAZELHaleon US Holdings LLCcebee3f7-8591-e4f7-e66a-e43b4ba3aaf42024-04-05WarningsExact identifier
application number: M015
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
application number: M015
Preparation HCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZELHaleon US Holdings LLC2f370875-0225-47b7-b43f-8fa4600d2a0e2024-04-05WarningsExact identifier
application number: M015
PREPARATION HCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa23ded81-78ba-c199-a8f0-aaf360b216ff2024-03-02WarningsExact identifier
application number: M015
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC3b1cfa8a-942f-471e-b7c0-744f83b687a02024-03-02WarningsExact identifier
application number: M015
PREPARATION H HYDROCORTISONEHYDROCORTISONEHaleon US Holdings LLCb8d531eb-4012-0450-0e4b-70a8084640412024-02-29WarningsExact identifier
application number: M015
PREPARATION HMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLHaleon US Holdings LLC507c08ab-a98b-33fe-e2ac-eb9b9a810d5a2024-02-29WarningsExact identifier
application number: M015
Preparation H Rapid ReliefLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC27db1d58-4609-4a80-af2f-9e36f10482e12024-02-29WarningsExact identifier
application number: M015
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
application number: M015
Numquick AnalgesicEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDEUnit Dose, Ltd.b66e7a91-9e35-64dd-e053-2a95a90a8b832024-02-28WarningsExact identifier
application number: M015
Medicated Wipes Hemorroidal Wipes With Witch HazelWITCH HAZELWuhan Zonsen Medical Products Co., Ltd.12441e46-5490-d45c-e063-6394a90a39e32024-02-26WarningsExact identifier
application number: M015
Lidocaine HemorrhoidLIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZELWalgreens Co10a47899-f4a0-66e8-e063-6394a90a11dd2024-02-05WarningsExact identifier
application number: M015
ER HemorrhoidPHENYLEPHRINE HCLEVER READY FIRST AID3cf29fc0-af4d-4610-a426-894601d5e0782024-02-02WarningsExact identifier
application number: M015
RRHOID RAGE HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEPOPPY COLLECTIVE LLCa02a6398-0acd-4aa7-8320-ac586ff12eb32024-01-31WarningsExact identifier
application number: M015
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
application number: M015
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
application number: M015
Prosoria Anti-Itch MoisturizerPRAMOXINE HYDROCHLORIDENuvothera, Inc.3c4b9515-f435-4227-a347-d6508778426d2024-01-10WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCICardinal Health 110 dba LEADERa5a261c2-1f36-c895-e053-2a95a90ab22b2024-01-02WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLProficient Rx LP105095e3-843e-4153-adc9-266dd14929a22024-01-01WarningsExact identifier
application number: M015
Family Wellness HEMORRHOIDGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLFAMILY DOLLAR (Family Wellness)16ceb129-5c0a-428a-a867-cfbbb08bb62a2023-12-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246075pramoxine HCl 1 % Topical LotionPSN674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246076Prax 1 % Topical LotionPSN674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246076pramoxine hydrochloride 10 MG/ML Topical Lotion [Prax]SBD674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCD674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246075pramoxine hydrochloride 1 % Topical LotionSY674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246076Prax 1 % Topical LotionSY674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246076Prax 10 MG/ML Topical LotionSY674f0d8b-3d50-42b1-8401-d2967bcdf5cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0496-0748-0300496074803237 mL in 1 BOTTLE (0496-0748-03) 237 ml2012-04-010000-00-00NoNoCurrent
0496-0748-0400496074804118 mL in 1 BOTTLE (0496-0748-04) 118 ml2012-04-010000-00-00NoNoCurrent
0496-0748-150049607481515 mL in 1 BOTTLE (0496-0748-15) 15 ml2012-04-010000-00-00NoNoCurrent