ElixirZincoCare

Product NDC: 84546-0004
11-digit product format: 845460004
Labeler code: 84546
Product ID: 84546-0004_44302810-1a9c-cd23-e063-6394a90a964f
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide 20%
Dosage form: OINTMENT
Route: TOPICAL
Labeler: ELIXIR HEALTHCARE USA, LLC.
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-12-31
Substance: ZINC OXIDE
Active strength: 20 g/100g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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: ElixirZincoCare
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198911	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
bac18496-3b76-4faf-abde-968d79b718d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84546-0004-1	ElixirZincoCare	28.3 g in 1 TUBE	OINTMENT	28.3	1
84546-0004-1	ElixirZincoCare	1 in 1 CARTON	OINTMENT	1	1
84546-0004-2	ElixirZincoCare	12 in 1 BOX	OINTMENT	12	1
84546-0004-2	ElixirZincoCare	6 in 1 CASE	OINTMENT	6	1
84546-0004-3	ElixirZincoCare	454 g in 1 JAR	OINTMENT	454	1

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 16 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACITRACIN	BACITRACIN	Meijer Distribution Inc	029e7150-1b9a-47c9-90bd-5f8bcd21365c	2024-10-29	Warnings	Exact identifier application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	A-S Medication Solutions	01131ba6-6d5b-4710-bec3-ba1769c08c79	2024-10-22	Warnings	Exact identifier application number: M004
BACITRACIN	BACITRACIN	CVS Pharmacy	15ea4415-943a-4d0a-ac23-5f37cd2cf206	2024-10-22	Warnings	Exact identifier application number: M004
Tetracyte First Aid and Antibiotic Topical	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	dcb3d96a-41a5-40d8-a47e-56d419bbe6e2	2024-10-21	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	CVS Pharmacy	3ba24e32-7078-45fb-85d1-2ab252fa9cb5	2024-10-16	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	43486da5-6e8b-45c0-bd7e-cc2d8b28c510	2024-10-16	Warnings	Exact identifier application number: M004
Genuine First Aid First Aid Antibiotic Bacitracin Zinc	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production (Xiamen) Co., Ltd.	af08c1fe-fb1a-56d2-e053-2a95a90a67c4	2024-10-15	Warnings	Exact identifier application number: M004
Exchange Select First Aid Triple Anitbiotic Pain Relieving	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Army & Air Force Exchange Service	1c7f1700-69c0-4a71-8bb0-a71e3082efeb	2024-10-14	Warnings	Exact identifier application number: M004
antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	55fa94cb-7e1c-41bc-879a-5618a828f14a	2024-10-14	Warnings	Exact identifier application number: M004
first aid antibiotic and pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer, Inc.	f0892a30-8a88-44e8-ab04-0e87c12f9c44	2024-10-14	Warnings	Exact identifier application number: M004
triple antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	d97a69e8-4058-4c77-b628-ad3e2b97a620	2024-10-14	Warnings	Exact identifier application number: M004
Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	b541f1a9-7e40-4c35-840f-ea1e357b580e	2024-10-14	Warnings	Exact identifier application number: M004
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	bac18496-3b76-4faf-abde-968d79b718d8	1
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	bac18496-3b76-4faf-abde-968d79b718d8	1
198911	zinc oxide 20 % Topical Ointment	SY	bac18496-3b76-4faf-abde-968d79b718d8	1
198911	zinc oxide 200 MG per GM Topical Ointment	SY	bac18496-3b76-4faf-abde-968d79b718d8	1
198911	ZNO 0.2 MG/MG Topical Ointment	SY	bac18496-3b76-4faf-abde-968d79b718d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84546-0004-1	84546000401	1 TUBE in 1 CARTON (84546-0004-1) / 28.3 g in 1 TUBE	1 tube	2025-12-31	No	No	Current
84546-0004-2	84546000402	6 BOX in 1 CASE (84546-0004-2) / 12 PACKET in 1 BOX / 56.7 g in 1 PACKET	6 box	2025-12-31	No	No	Current
84546-0004-3	84546000403	454 g in 1 JAR (84546-0004-3)	454 g	2025-12-31	No	No	Current