Tripleantibioticointmentandpainrelief

Product NDC: 69396-044
11-digit product format: 693960044
Labeler code: 69396
Product ID: 69396-044_29b3e33a-544c-40b4-e063-6394a90a1107
Type: HUMAN OTC DRUG
Nonproprietary name: Family Wellness Bacitracin,Neomycin,PolymyxinB,Pramoxine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Trifecta Pharmaceutical USA LLC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-08-30
Substance: BACITRACIN; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Active strength: 500; 3.5; 10; 10000 [USP'U]/100g; mg/100g; mg/100g; [USP'U]/100g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
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: Tripleantibioticointmentandpainrelief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN	500 [USP'U]/100g
NEOMYCIN SULFATE	3.5 mg/100g
PRAMOXINE HYDROCHLORIDE	10 mg/100g
POLYMYXIN B SULFATE	10000 [USP'U]/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
58H6RWO52I	Internal UNII lookup
057Y626693	Internal UNII lookup
88AYB867L5	Internal UNII lookup
19371312D4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1359350	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
91575333-5268-5d8f-e053-2a95a90a7a89	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
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69396-044-01	Tripleantibioticointmentandpainrelief	28.4 g in 1 TUBE	OINTMENT	28.4		4
69396-044-01	Tripleantibioticointmentandpainrelief	1 in 1 BOX	OINTMENT	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-044	TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF (FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE) OINTMENT [TRIFECTA PHARMACEUTICAL USA LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241222_91575333-5268-5d8f-e053-2a95a90a7a89.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 17 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Exchange Select triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Army & Air Force Exchange Service	b7bf899c-44e5-48d6-bf8e-d843fd442432	2024-10-12	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Topco Associates LLC	675665ee-bd0d-4168-81b8-341b1258c102	2024-10-12	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Hubei Changjian Medical Products Co., Ltd.	34e8776c-1f36-4e1b-9d71-727591ac904d	2024-10-11	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	H E B	58a4d263-e234-43cd-a3bd-b19a492174d9	2024-10-11	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	5e0fc39b-e6d4-4543-8afc-2881e2f85f9b	2024-10-06	Warnings	Exact identifier application number: M004
Good Sense Triple Antibiotic and Pain Relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	L. Perrigo Company	c3e9215f-fcef-4938-8208-df4099652289	2024-10-06	Warnings	Exact identifier application number: M004
triple antibiotic plus maximum strength	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	c428b0a3-e80a-493c-ac67-807ebca3ce01	2024-10-06	Warnings	Exact identifier application number: M004
Basic Care First Aid Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amazon.com Services LLC	a9247f69-0366-42dd-ae0d-39a2a6976cdc	2024-10-06	Warnings	Exact identifier application number: M004
Triple Antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Kroger Company	e31c8d92-bf9f-4b7f-8f81-54199745cd20	2024-10-06	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	American Sales Company	9df0c4c2-f045-4f25-878e-4d55a99b8df4	2024-10-06	Warnings	Exact identifier application number: M004
DG Health Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp, LLC	0a04da51-d169-4eff-b70c-352913ce3966	2024-10-06	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	8d5bac6b-98b6-4fc4-983a-ca5292b4c361	2024-10-06	Warnings	Exact identifier application number: M004
antibiotic plus pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Kroger Company	91828614-d0d1-472f-802f-43f473860125	2024-09-26	Warnings	Exact identifier application number: M004
DG Health Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp Inc	efaf3ea5-0a2f-414f-96eb-7e8cfba9e901	2024-09-26	Warnings	Exact identifier application number: M004
Good Sense First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	A-S Medication Solutions	29c223ff-3cb7-4578-a326-08516e89cd47	2024-09-26	Warnings	Exact identifier application number: M004
Signature Care First Aid Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	78ecfb28-f4c4-4f70-90c9-d6d7bf920fb5	2024-09-26	Warnings	Exact identifier application number: M004
Good Neighbor Pharmacy Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amerisource Bergen	3d1694ea-3f3e-45d5-8edf-8b31ac7d3a40	2024-09-26	Warnings	Exact identifier application number: M004
Rexall Antibiotic	BACITRACIN	Dolgencorp, LLC	7ad42602-6e42-47c8-91a8-e4785fa8d24b	2024-09-23	Warnings	Exact identifier application number: M004
bacitracin	BACITRACIN	H E B	0a5eeef0-309b-4edd-a664-3d9c1c74a6e9	2024-09-23	Warnings	Exact identifier application number: M004
signature care first aid antibiotic	BACITRACIN	Safeway	38fc0c5c-e0bc-44d2-acbd-d4d329fef1e1	2024-09-23	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
58H6RWO52I	BACITRACIN	1405-87-4	BACITRACIN
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1359350	bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical Ointment	PSN	91575333-5268-5d8f-e053-2a95a90a7a89	4
1359350	bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment	SCD	91575333-5268-5d8f-e053-2a95a90a7a89	4
1359350	bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Ointment	SY	91575333-5268-5d8f-e053-2a95a90a7a89	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69396-044-01	69396004401	1 TUBE in 1 BOX (69396-044-01) / 28.4 g in 1 TUBE	1 tube	2019-09-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triple Antibiotic Ointment + Pain Relief	Trifecta Pharmaceutical USA LLC	2024-12-20	HUMAN OTC DRUG LABEL	4