Flavoxate Hydrochloride Tablets, 100 mg Film-Coated

Manufacturer: Physicians Total Care, Inc.
Effective date: 2012-01-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:13:58

Label at a glance#

ProductFlavoxate Hydrochloride

Active ingredientFlavoxate hydrochloride

Label structure13 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#

SPL UNCLASSIFIED SECTION

Rx Only

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-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C₂₄H₂₅NO₄•HCl. The molecular weight is 427.94. The structural formula appears below.

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. titanium dioxide and triacetin.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

MECHANISM OF ACTION 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

TERATOGENIC EFFECTS SECTION

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 Mother

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 LD₅₀ 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 "Ɛ58" on one side and plain on the other side, and are available in

Bottles of 10	NDC 54868-6326-1
Bottles of 90	NDC 54868-6326-0

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

Manufactured by
Epic Pharma, LLC
Laurelton, NY 11413

Made in USA

Distributed by:
TAGI Pharma
South Beloit, IL 61080

Issued 02/11
MF058ISS02/11
OE1252

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PRINCIPAL DISPLAY PANEL - 100 mg Tablets Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Flavoxate
Hydrochloride
Tablets

100 mg

Rx Only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1095229	flavoxATE HCl 100 MG Oral Tablet	PSN	1
1095229	flavoxate hydrochloride 100 MG Oral Tablet	SCD	1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54868-6326-0	2019-09-24	C162847	48780-1	9350213a-47cf-c013-e053-90daa90a1393	Flavoxate Hydrochloride Tablets, 100 mg Film-Coated
54868-6326-1	2019-09-24	C162847	48780-1	9350213a-47cf-c013-e053-90daa90a1393	Flavoxate Hydrochloride Tablets, 100 mg Film-Coated

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54868-6326-0	Flavoxate Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		1
54868-6326-1	Flavoxate Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-6326	FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1	2 package rows	20120126_e05f4892-0be8-4178-a274-3289edca0137.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-6326-0	EA - Each	54868-6326	2fcc057c-745c-480b-b8ae-0db55be6e5fb	1	2012-07-24
54868-6326-1	EA - Each	54868-6326	20354c4f-b815-45dd-aede-6e1e92ab0287	1	2012-07-24
51224-154-50	EA - Each	51224-154	da0ca5dc-9e37-4122-8965-4d96d4260b77	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Flavoxate hydrochloride	ACTIVE INGREDIENT	9C05J6089W	1
Flavoxate	ACTIVE MOIETY	3E74Y80MEY	1
dibasic calcium phosphate dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Flavoxate Hydrochloride
Flavoxate
silicon dioxide
starch, corn
dibasic calcium phosphate dihydrate
magnesium stearate
hypromelloses
polydextrose
titanium dioxide
triacetin

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54868-6326	54868-6326-0, 54868-6326-1
51224-154

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Flavoxate hydrochloride	9C05J6089W	ACTIB
silicon dioxide	ETJ7Z6XBU4	IACT
starch, corn	O8232NY3SJ	IACT
dibasic calcium phosphate dihydrate	O7TSZ97GEP	IACT
magnesium stearate	70097M6I30	IACT
hypromelloses	3NXW29V3WO	IACT
polydextrose	VH2XOU12IE	IACT
titanium dioxide	15FIX9V2JP	IACT
triacetin	XHX3C3X673	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 4 · 204 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	SYSTEM / TRANSDERMAL	22.1 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, EXTENDED RELEASE / ORAL		22 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	CAPSULE, EXTENDED RELEASE / ORAL		467 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	SYRUP / ORAL		250 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	CAPSULE, DELAYED RELEASE / ORAL	5.1 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	CONCENTRATE / ORAL		250 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
dibasic calcium phosphate dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	PASTE, DENTIFRICE / DENTAL	51 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
dibasic calcium phosphate dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	CAPSULE, EXTENDED RELEASE / ORAL		51 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	SUSPENSION / ORAL		7 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	TABLET / ORAL		208 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 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
5b1c1400-be20-4fd6-b6c5-e23cbbcc70bd			e05f4892-0be8-4178-a274-3289edca0137	2012-01-25	Warnings, Adverse reactions	Exact identifier spl id: 5b1c1400-be20-4fd6-b6c5-e23cbbcc70bd spl set id: e05f4892-0be8-4178-a274-3289edca0137

Reported adverse events (FAERS/openFDA)#

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