FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF

Product NDC: 55319-033
11-digit product format: 553190033
Labeler code: 55319
Product ID: 55319-033_80c68765-ae5a-d554-e053-2a91aa0a966f
Type: HUMAN OTC DRUG
Nonproprietary name: Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine HCI
Dosage form: CREAM
Route: TOPICAL
Labeler: FAMILY DOLLAR
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-10-15
Marketing end: 0000-00-00
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength: 4 mg/g; [USP'U]/g; mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55319-033		I	Inactivated by FDA		2026-10-12
excluded package	package	55319-033	55319-033-28	I	Inactivated by FDA		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-033-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-033-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55319-033-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55319-033-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55319-033-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55319-033-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55319-033-28	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55319-033-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55319-033-28	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55319-033-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55319-033-28	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55319-033-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55319-033-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55319-033-28	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55319-033-28	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55319-033-28	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55319-033-28	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55319-033-28	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55319-033-28	2022-01-28	C162847	48780-1	d6a99b39-6a15-a426-e053-dadaa90af4c2	Family Wellness Triple Antibiotic Pain Relief Cream 1 oz. 3326 (2018)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55319-033-28	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF	28 g in 1 TUBE	CREAM	28		5
55319-033-28	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF	1 in 1 CARTON	CREAM	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NEOMYCIN	ACTIVE INGREDIENT	I16QD7X297	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
PRAMOXINE	ACTIVE MOIETY	068X84E056	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-033	FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HCI) CREAM [FAMILY DOLLAR]	5	Legacy NDC, 2 package rows	20190201_9f0313a2-3e80-4b93-8362-3e5ea55b29e7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	PSN	9f0313a2-3e80-4b93-8362-3e5ea55b29e7	5
1359360	neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	9f0313a2-3e80-4b93-8362-3e5ea55b29e7	5
1359360	neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical Cream	SY	9f0313a2-3e80-4b93-8362-3e5ea55b29e7	5
1359360	neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream	SY	9f0313a2-3e80-4b93-8362-3e5ea55b29e7	5
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	SY	9f0313a2-3e80-4b93-8362-3e5ea55b29e7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-033-28	55319003328	1 TUBE in 1 CARTON (55319-033-28) > 28 g in 1 TUBE	1 tube	2012-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Family Wellness Triple Antibiotic Pain Relief Cream 1 oz. 3326 (2018)	FAMILY DOLLAR	2019-01-31	HUMAN OTC DRUG LABEL	5