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
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
674f0d8b-3d50-42b1-8401-d2967bcdf5cf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0496-0748-03	PRAX	237 mL in 1 BOTTLE	LOTION	237	3
0496-0748-04	PRAX	118 mL in 1 BOTTLE	LOTION	118	3
0496-0748-15	PRAX	15 mL in 1 BOTTLE	LOTION	15	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0496-0748-03	ML - Milliliter	0496-0748	b6504dad-0912-4d55-9453-e5d6c6a530c0	1	2013-07-02
0496-0748-04	ML - Milliliter	0496-0748	b54a913e-a7ae-4fa8-ac21-94664fed7c1b	1	2013-07-02
0496-0748-15	ML - Milliliter	0496-0748	04165e3a-56fa-4666-879e-9ba452700668	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
DIISOPROPYL ADIPATE	INACTIVE INGREDIENT	P7E6YFV72X	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
HYDROGENATED COCONUT OIL	INACTIVE INGREDIENT	JY81OXM1OM	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0496-0748	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20241219_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 18 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemorrhoid Pain Relief	LIDOCAINE	Telebrands Corp	04164425-ca3b-ef24-e063-6294a90a59d8	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic	LIDOCAINE	Telebrands Corp	f525075a-d7ee-dad0-e053-2a95a90a6f3f	2024-11-20	Warnings	Exact identifier application number: M015
Curist Lidocaine Numbing Relief	LIDOCAINE	Little Pharma, Inc.	bff3c422-a0df-6196-e053-2a95a90af033	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum	LIDOCAINE 5%	Telebrands Corp	2774ec41-7366-ac8c-e063-6394a90a1ee2	2024-11-20	Warnings	Exact identifier application number: M015
Walgreens Anorectal Lidocaine Cream	5% LIDOCAINE	Walgreens Company	3052fac7-fd68-43f4-9950-8c07288a6b6d	2024-11-20	Warnings	Exact identifier application number: M015
Lidocaine Anorectal	LIDOCAINE	Patrin Pharma, Inc	456d41fe-8449-4980-9291-d7a3b65a900d	2024-11-13	Warnings	Exact identifier application number: M015
MyDerm	PENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,	Inspec Solution LLC.	2618eba1-9308-a666-e063-6394a90ac3d2	2024-11-04	Warnings	Exact identifier application number: M015
Granulotion Medicated	MENTHOL, ZINC OXIDE	GL HEALTH, INC.	01701780-b160-415b-b34d-362237179475	2024-10-29	Warnings	Exact identifier application number: M015
rexall hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Dolgencorp Inc	0415c51b-5a12-49d4-8968-0131ddb85545	2024-10-23	Warnings	Exact identifier application number: M015
Exchange Select Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Army & Air Force Exchange Service	8155ed74-9412-498f-998c-4a29c46e934f	2024-10-23	Warnings	Exact identifier application number: M015
Leader Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	c4814524-0f4c-4351-a431-5b4b6431fd28	2024-10-23	Warnings	Exact identifier application number: M015
basic care hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Amazon.com Services LLC	617d9213-31f0-4c71-be0c-7961b96e5143	2024-10-23	Warnings	Exact identifier application number: M015
Signature Care Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Safeway	e74b71a1-915d-4e5b-b548-d5cce7945dbd	2024-10-23	Warnings	Exact identifier application number: M015
Equaline Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	d29b7824-ff9e-4875-b3de-92721c8add0e	2024-10-23	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Publix Super Markets Inc	a241cb37-7007-4fd8-a12e-f3fc6d6f780e	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Kroger Company	d44ca22a-dc20-454d-99aa-403a8c7a3e00	2024-10-22	Warnings	Exact identifier application number: M015
rugby hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Rugby Laboratories	c1a126b5-0d34-437f-a7ef-8d5cbeb7b03b	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Meijer Distribution Inc	1431397e-3515-4794-a494-70667948e14c	2024-10-18	Warnings	Exact identifier application number: M015
signature care hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Safeway	afcf68cf-f187-44d3-ad91-b1e79b182bc6	2024-10-17	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	H E B	1435432d-5ff2-468b-808d-fb0c99a0717b	2024-10-17	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1246075	pramoxine HCl 1 % Topical Lotion	PSN	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246076	Prax 1 % Topical Lotion	PSN	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246076	pramoxine hydrochloride 10 MG/ML Topical Lotion [Prax]	SBD	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246075	pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246075	pramoxine hydrochloride 1 % Topical Lotion	SY	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246076	Prax 1 % Topical Lotion	SY	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246076	Prax 10 MG/ML Topical Lotion	SY	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0496-0748-03	00496074803	237 mL in 1 BOTTLE (0496-0748-03)	237 ml	2012-04-01	0000-00-00	No	No	Current
0496-0748-04	00496074804	118 mL in 1 BOTTLE (0496-0748-04)	118 ml	2012-04-01	0000-00-00	No	No	Current
0496-0748-15	00496074815	15 mL in 1 BOTTLE (0496-0748-15)	15 ml	2012-04-01	0000-00-00	No	No	Current