Flavoxate Hydrochloride Tablets 100 mg, Film-Coated Rx only

Manufacturer: Epic Pharma, LLC
Effective date: 2023-12-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-05-31 20:56:57

Label at a glance#

ProductFlavoxate Hydrochloride

Active ingredientFLAVOXATE HYDROCHLORIDE

Label structure11 sections

Indications and uses

Flavoxate hydrochloride tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.

Dosage and administration

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Flavoxate hydrochloride tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4 H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C ₂₄H ₂₅NO ₄•HCl. The molecular weight is 427.94. The structural formula appears below.

Structure Formula

Each tablet for oral administration contains 100 mg flavoxate hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate hydrochloride was excreted in the urine within 24 hours.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Flavoxate hydrochloride is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

WARNINGS

WARNINGS SECTION

Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.

PRECAUTIONS

PRECAUTIONS SECTION

Information for Patients

INFORMATION FOR PATIENTS SECTION

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate hydrochloride have not been performed.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects-Pregnancy Category B

SPL UNCLASSIFIED SECTION

Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate hydrochloride. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

NURSING MOTHERS SECTION

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

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness in children below the age of 12 years have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Renal: Dysuria.

OVERDOSAGE

OVERDOSAGE SECTION

The oral LD₅₀ for flavoxate hydrochloride in rats is 4273 mg/kg. The oral LD ₅₀ for flavoxate hydrochloride in mice is 1837 mg/kg.

It is not known whether flavoxate hydrochloride is dialyzable.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age

SPL UNCLASSIFIED SECTION

HOW SUPPLIED

HOW SUPPLIED SECTION

Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ Є58” on one side and plain on the other side, and are available as follows:

NDC 42806-058-01 Bottles of 100

NDC 42806-058-10 Bottles of 1000

Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container.

Distributed by

Epic Pharma, LLC

Laurelton, NY 11413

Rev. 07-2023-00

MF058REV07/23

OE1140

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg 100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Flavoxate Hydrochloride Tablets, 100 mg 100ct

flavoxate-100mg-100ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1095229	flavoxATE HCl 100 MG Oral Tablet	PSN	11
1095229	flavoxate hydrochloride 100 MG Oral Tablet	SCD	11

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42806-058-01	Flavoxate Hydrochloride	100 in 1 BOTTLE	TABLET	100		11
42806-058-10	Flavoxate Hydrochloride	1000 in 1 BOTTLE	TABLET	1000		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-058	FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]	11	Current NDC, Legacy NDC, 2 package rows	20231228_b4260d7e-2ab3-49f6-aa57-bae19a23d82a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42806-058-01	EA - Each	42806-058	b9340ad4-66dd-4477-a9c6-5bd0d3360794	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FLAVOXATE HYDROCHLORIDE	ACTIVE INGREDIENT	9C05J6089W	4
FLAVOXATE	ACTIVE MOIETY	3E74Y80MEY	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	4
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	4
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	4

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Flavoxate Hydrochloride
SILICON DIOXIDE
STARCH, CORN
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (50 MPA.S)
POLYDEXTROSE
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
TRIACETIN
FLAVOXATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42806-058	42806-058-01, 42806-058-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	O7TSZ97GEP	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (50 MPA.S)	1IVH67816N	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
FLAVOXATE HYDROCHLORIDE	9C05J6089W	ACTIB

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 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYDEXTROSE	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL	20 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET / ORAL	208 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYDEXTROSE	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL	20 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET / ORAL	208 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYETHYLENE GLYCOL 8000	POLYETHYLENE GLYCOL 8000	Q662QK8M3B	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYETHYLENE GLYCOL 8000	POLYETHYLENE GLYCOL 8000	Q662QK8M3B	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYDEXTROSE	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL	20 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYETHYLENE GLYCOL 8000	POLYETHYLENE GLYCOL 8000	Q662QK8M3B	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET / ORAL	208 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 3 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 44.

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
A076835-001	FLAVOXATE HYDROCHLORIDE	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2005-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076835-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A076835-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076835-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076835-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076835-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076835-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076835-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076835-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076835-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076835-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076835-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076835-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076835-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076835-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076835-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076835-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076835-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076835-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076835-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076835-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076835-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076835-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076835-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076835-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076835-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076835-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076835-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076835-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076835-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076835-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076835-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076835-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076835-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076835-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076835-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076835-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076835-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076835-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076835-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076835-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076835-001	AB	1	`3a93d1ddd44b…`

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
Flavoxate Hydrochloride	FLAVOXATE HYDROCHLORIDE	Epic Pharma, LLC	b4260d7e-2ab3-49f6-aa57-bae19a23d82a	2023-12-27	Warnings, Adverse reactions	Exact identifier ndc (package): 42806-058-10 ndc (package): 42806-058-01 ndc (product): 42806-058 ndc11 (package): 42806005810 ndc11 (package): 42806005801 spl id: 6aeb8856-3df7-40a7-b03e-d855a58c8fa4 spl set id: b4260d7e-2ab3-49f6-aa57-bae19a23d82a

Reported adverse events (FAERS/openFDA)#

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