Griseofulvin Oral Suspension

Manufacturer: TriRx Huntsville Pharmaceutical Services LLC | TriRx Huntsville Pharmaceutical Services
Effective date: 2023-01-10
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 21:41:20

Label at a glance#

ProductGriseofulvin Oral Suspension

Active ingredientGRISEOFULVIN

Label structure17 sections

Label contents#

Full prescribing information#

ADVERSE REACTIONS SECTION

Adverse Reactions

Adverse reactions 2

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

CMF-1

CMF-2

CLINICAL PHARMACOLOGY SECTION

Clinical Pharmacology

Clinical Pharmacology-2

Clinical Pharmacology-3

CONTRAINDICATIONS SECTION

Contraindications-1

Contraindications-2

Contraindications-3

DESCRIPTION SECTION

Description-2Description-1

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration-1

Dosage and Administration-2

dosage and administration 3

Dosage and Administration-4

dosage and administration 4

DRUG INTERACTIONS SECTION

Drug Interactions-1

drug interactions-2

HOW SUPPLIED SECTION

How Supplied

INDICATIONS & USAGE SECTION

Indications and Usage-1

Indications and Usage-2

Indications and Usage-3

MICROBIOLOGY SECTION

microbiology

OVERDOSAGE SECTION

Overdosage

PEDIATRIC USE SECTION

Pediatric Use

PRECAUTIONS SECTION

Precautions

PREGNANCY SECTION

pregnancy

WARNINGS SECTION

Warnings and Precautions

Hepatotoxicity

NURSING MOTHERS SECTION

Nursing Mothers

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

primary package label-bottle

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Griseofulvin Oral Suspension
DIMETHICONE
ORANGE
GRISEOFULVIN
METHYLPARABEN
DOCUSATE SODIUM
MAGNESIUM ALUMINUM SILICATE
MENTHOL, (+)-
PROPYLPARABEN
PROPYLENE GLYCOL, (R)-
WATER
ALCOHOL
FD&C YELLOW NO. 6
SACCHARIN SODIUM
FD&C RED NO. 40
SUCROSE
SODIUM ALGINATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80432-056	80432-056-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	IACT
ORANGE	5EVU04N5QU	IACT
GRISEOFULVIN	32HRV3E3D5	ACTIB
METHYLPARABEN	A2I8C7HI9T	IACT
DOCUSATE SODIUM	F05Q2T2JA0	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
MENTHOL, (+)-	C6B1OE8P3W	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PROPYLENE GLYCOL, (R)-	602HN5L69H	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
SUCROSE	C151H8M554	IACT
SODIUM ALGINATE	C269C4G2ZQ	IACT

Source Document#

Source XML

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
A065438-001	GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	125MG/5ML	SUSPENSION / ORAL	AB		2010-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065438-001	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065438-001	GRISEOFULVIN	125MG/5ML	SUSPENSION / ORAL	AB	2010-10-08	`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	A065438-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065438-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065438-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065438-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065438-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065438-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065438-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065438-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065438-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065438-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065438-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065438-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065438-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065438-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065438-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065438-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065438-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065438-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065438-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065438-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065438-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065438-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065438-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065438-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065438-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065438-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065438-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065438-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065438-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065438-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065438-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065438-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065438-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065438-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065438-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065438-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065438-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065438-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065438-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065438-001	AB	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
f1ea506d-0062-7849-e053-2995a90a94ea			f1ea506d-0061-7849-e053-2995a90a94ea	2023-01-10	Warnings, Adverse reactions	Exact identifier spl id: f1ea506d-0062-7849-e053-2995a90a94ea spl set id: f1ea506d-0061-7849-e053-2995a90a94ea

Reported adverse events (FAERS/openFDA)#

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