Publix

Product NDC: 41415-076
11-digit product format: 414150076
Labeler code: 41415
Product ID: 41415-076_39fe9230-350d-06e0-e063-6394a90a2f59
Type: HUMAN OTC DRUG
Nonproprietary name: Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Publix Super Markets Inc
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-03-21
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength: 3.5; 10000; 10 mg/g; [iU]/g; mg/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 16 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
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	41415-076-75	`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	41415-076-75	`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	41415-076-75	`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	41415-076-75	`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	41415-076-75	`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	41415-076-75	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	41415-076-75	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	41415-076-75	`9bebd1f3094a…`	`5416666fcb17…`

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: Publix
Brand name suffix: antibiotic plus Pain Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/g
POLYMYXIN B SULFATE	10000 [iU]/g
PRAMOXINE HYDROCHLORIDE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
057Y626693	Internal UNII lookup
19371312D4	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1359360	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
d0193bf1-a257-490e-a058-5e6a514981da	Available on FDA.report

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#

Effective, Related label table
Effective	Related label
2024-11-14	Publix antibioticcream plus Pain Relief
2024-01-30	Publix antibioticcream plus Pain Relief
2021-12-15	Publix antibioticcream plus Pain Relief
2020-01-31	Publix antibioticcream plus Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41415-076-75	Publixantibiotic plus Pain Relief	1 in 1 CARTON	CREAM	1		4
41415-076-75	Publixantibiotic plus Pain Relief	28.4 g in 1 TUBE	CREAM	28.4		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Neomycin sulfate	ACTIVE INGREDIENT	057Y626693	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
Polymyxin B sulfate	ACTIVE INGREDIENT	19371312D4	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
Pramoxine hydrochloride	ACTIVE INGREDIENT	88AYB867L5	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
Neomycin	ACTIVE MOIETY	I16QD7X297	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
Pramoxine	ACTIVE MOIETY	068X84E056	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41415-076	PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]	3	Current NDC, Legacy NDC, 2 package rows	20241116_d0193bf1-a257-490e-a058-5e6a514981da.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 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Balma Septic Antiseptic Hand Wash	BENZALKONIUM CHLORIDE	Rochester Midland Corporation	1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528	2025-01-10	Warnings	Exact identifier application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380	CHLOROXYLENOL	ABC Compounding Co., Inc.	efa3938f-64de-77ba-e053-2a95a90ac840	2025-01-10	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	A-S Medication Solutions	64aa660d-2d69-48e8-bd0d-4876815d89ff	2025-01-08	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Water-Jel Technologies	412928a1-3708-4fa8-99c5-aaa2b079cf6e	2025-01-06	Warnings	Exact identifier application number: M004
AVON HeXashield Triple Antibiotic with Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Tai Guk Pharm. Co., Ltd.	8e0cb861-d8aa-1f71-e053-2a95a90aaa88	2025-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA LLC	087694c2-4b1b-e293-e063-6294a90a961f	2024-12-31	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	TRIFECTA PHARMACEUTICALS USA LLC	0c017b10-29b6-e30f-e063-6294a90a8a3c	2024-12-31	Warnings	Exact identifier application number: M004
Triple Antibiotic and Pain Relief	BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	0bf08cf6-be3f-f9aa-e063-6294a90a4393	2024-12-31	Warnings	Exact identifier application number: M004
Single Antibiotic with Bacitracin	BACITRACIN ZINC	Randob Labs Ltd.	2a807f1b-986f-a9ea-e063-6394a90aed25	2024-12-30	Warnings	Exact identifier application number: M004
Tripleantibioticapainscaritch	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCL	Trifecta Pharmaceutical USA LLC	935106c6-8a9e-07fa-e053-2a95a90a2484	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	00c52a31-9bfa-a8bf-e063-6294a90ac4d7	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	Trifecta Pharmaceuticals Usa Llc	d04b397c-1608-4fd9-be28-ef7285d6a996	2024-12-20	Warnings	Exact identifier application number: M004
Tripleantibioticointmentandpainrelief	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	91575333-5268-5d8f-e053-2a95a90a7a89	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Max Strength Antibiotic plus pain relief	PREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Pharmacy Value Alliance LLC	9767821e-054b-3bd3-e053-2a95a90a4b0e	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab843664-a1e0-6716-e053-2995a90a2063	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Bacitracin Zinc	BACITRACIN ZINC	Pharmacy Value Alliance LLC	99d789be-aa85-0917-e053-2a95a90acd13	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab863d90-1a8f-3c1f-e053-2a95a90aa0a7	2024-12-20	Warnings	Exact identifier application number: M004
Family Wellness First Aid Antibiotic	FAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA, LLC	9157681a-3ed1-096e-e053-2a95a90a05e3	2024-12-18	Warnings	Exact identifier application number: M004
Family Wellness Original	FAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN B	Trifecta Pharmaceuticals USA LLC.	915759af-0d4f-6a87-e053-2a95a90acbd6	2024-12-18	Warnings	Exact identifier application number: M004
Family Wellness Pain Scar Itch	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Trifecta Pharmaceutical USA LLC	9e507ec5-310d-3a21-e053-2a95a90a15a6	2024-12-18	Warnings	Exact identifier application number: M004

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	d0193bf1-a257-490e-a058-5e6a514981da	4
1359360	neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	d0193bf1-a257-490e-a058-5e6a514981da	4
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	d0193bf1-a257-490e-a058-5e6a514981da	4
1359360	neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream	SY	d0193bf1-a257-490e-a058-5e6a514981da	4
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	SY	d0193bf1-a257-490e-a058-5e6a514981da	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41415-076-75	41415007675	1 TUBE in 1 CARTON (41415-076-75) / 28.4 g in 1 TUBE	1 tube	2012-03-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Publix antibioticcream plus Pain Relief	Publix Super Markets Inc \| Sun Pharma Canada Inc.	2025-07-15	HUMAN OTC DRUG LABEL	4