NYSTATIN ORAL SUSPENSION, USP

Manufacturer: Physicians Total Care, Inc.
Effective date: 2010-06-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:11:55

Label at a glance#

ProductNYSTATIN

Active ingredientNYSTATIN

Label structure12 sections

Indications and uses

Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

Dosage and administration

INFANTS: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS: 4–6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). T...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

(100,000 units per mL)

Rx only

DESCRIPTION

DESCRIPTION SECTION

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:

Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C yellow #10, FD&C red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Pharmacokinetics

PHARMACOKINETICS SECTION

Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.

Microbiology

SPL UNCLASSIFIED SECTION

Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects Category C

TERATOGENIC EFFECTS SECTION

Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.

Nursing Mothers

NURSING MOTHERS SECTION

It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

See DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General).

Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic: Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported.

OVERDOSAGE

OVERDOSAGE SECTION

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

INFANTS: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes).
NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

CHILDREN AND ADULTS: 4–6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

HOW SUPPLIED

HOW SUPPLIED SECTION

Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a fruit flavored, light creamy yellow, ready-to-use suspension.

60 mL bottle w/ calibrated dropper	NDC 54868-0243-1
473 mL (1 Pint) bottle	NDC 54868-0243-0

Storage

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing

SPL UNCLASSIFIED SECTION

Rx Only

Product No.: 8537

Manufactured For:
Wockhardt USA, LLC
Parsippany, NJ 07054

Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

28537B
REV. 09-09

Relabeling of "Additional" label by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NYSTATIN ORAL
SUSPENSION, USP
(100,000 units per mL)

Fruit Flavored

SHAKE WELL BEFORE USING

Packaged with Calibrated Dropper

SAFETY SEALED BOTTLE

Rx Only

NET: 2 fl oz (60 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NYSTATIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
e57b6340-9387-3f9a-7307-511c81791375	Product name	3	20221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7	Product name	5	20210614
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97a	Product name	3	20180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54868-0243-0	2019-09-24	C162847	48780-1	9350213a-3f53-c013-e053-90daa90a1393	NYSTATIN ORAL SUSPENSION, USP
54868-0243-1	2019-09-24	C162847	48780-1	9350213a-3f53-c013-e053-90daa90a1393	NYSTATIN ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54868-0243-0	NYSTATIN	473 mL in 1 BOTTLE, PLASTIC	SUSPENSION	473	1
54868-0243-0	NYSTATIN	1 in 1 CARTON	SUSPENSION	1	1
54868-0243-1	NYSTATIN	1 in 1 CARTON	SUSPENSION	1	1
54868-0243-1	NYSTATIN	60 mL in 1 BOTTLE, GLASS	SUSPENSION	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-0243	NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1	4 package rows	20110511_f7a98d15-ce46-4358-ac6e-d10afa4d34c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-0243-0	ML - Milliliter	54868-0243	b83e8d8c-ce6c-439a-b2dd-3dc597237bc3	1	2012-07-24
54868-0243-1	ML - Milliliter	54868-0243	9c8f1ed4-42dc-4050-96de-8aa2ce46121b	1	2012-07-24
60432-537-16	ML - Milliliter	60432-537	4cade063-c2f1-481b-8ce0-2f183b5989df	1	2012-07-24
60432-537-60	ML - Milliliter	60432-537	a627d2f6-c5a2-4e15-80fc-69e008e6482b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	1
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POTASSIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	CI71S98N1Z	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NYSTATIN
WATER
MAGNESIUM ALUMINUM SILICATE
PROPYLENE GLYCOL
GLYCERIN
SUCROSE
POTASSIUM PHOSPHATE, DIBASIC
ALCOHOL
METHYLPARABEN
PROPYLPARABEN
D&C YELLOW NO. 10
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54868-0243	54868-0243-1, 54868-0243-0
60432-537

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NYSTATIN	BDF1O1C72E	ACTIB
WATER	059QF0KO0R	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCERIN	PDC6A3C0OX	IACT
SUCROSE	C151H8M554	IACT
POTASSIUM PHOSPHATE, DIBASIC	CI71S98N1Z	IACT
ALCOHOL	3K9958V90M	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C RED NO. 40	WZB9127XOA	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 494 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE / ORAL	20 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CONCENTRATE / ORAL	0.03 mg/1ml		Exact identifier — unii candidate 31 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET / ORAL	60 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOAP / TOPICAL	1.4 %w/w		Exact identifier — unii candidate 31 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CONCENTRATE / ORAL	410 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062512-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A062512-001	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A062512-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062512-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062512-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062512-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062512-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062512-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062512-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062512-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062512-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062512-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062512-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062512-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062512-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062512-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062512-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062512-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062512-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062512-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062512-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062512-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062512-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062512-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062512-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062512-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062512-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062512-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062512-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062512-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062512-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062512-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062512-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062512-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062512-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062512-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062512-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062512-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062512-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062512-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062512-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062512-001	AA	1	`f41ea6bd6efb…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6a6f2f48-f360-4f4d-a59a-22c77cd6a678			f7a98d15-ce46-4358-ac6e-d10afa4d34c2	2010-06-28	Adverse reactions	Exact identifier spl id: 6a6f2f48-f360-4f4d-a59a-22c77cd6a678 spl set id: f7a98d15-ce46-4358-ac6e-d10afa4d34c2

Reported adverse events (FAERS/openFDA)#

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