NDC 52959-669 - Sentraflox AM-10

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 52959-669
Package NDCs from labels: 52959-669-30
Manufacturer: Physician Therapeutics LLC | Pliva | H.J. Harkins Company, Inc. | Targeted Medical Pharma, Inc.
Effective date: 2011-08-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Sentraflox AM-10	Physician Therapeutics LLC \| Pliva \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma, Inc.	2011-08-17	HUMAN PRESCRIPTION DRUG LABEL
Sentroxatine	Physician Therapeutics LLC \| Pliva \| H.J. Harkins Company, Inc \| Targeted Medical Pharma, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL
Gaboxetine	Physician Therapeutics LLC \| Pliva \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-669-30	Sentroxatine	30 in 1 BOTTLE	CAPSULE	30	10 mg	9
52959-669-30	Sentraflox AM-10	30 in 1 BOTTLE	CAPSULE	30	10 mg	9
52959-669-30	Gaboxetine	30 in 1 BOTTLE	CAPSULE	30	10 mg	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-669	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9	Unmatched	20110818_35fee753-acd7-4da2-bd60-973dc6c0b21f.zip
52959-669	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9	Unmatched	20110815_83df297b-6467-451e-af4d-2c1f996cd009.zip
52959-669	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8	Unmatched	20110815_52057058-abdb-44ed-b60d-a718c97fbfda.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8

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 82 of 114 · 2,263 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100	TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S A	e4bb5a32-c5dc-86d5-e053-2a95a90a4938	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber	ZINC OXIDE, TITANIUM DIOXIDE	Alumier Labs	ba864a08-e66d-d286-e053-2995a90a1854	2024-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Sheer Hydration	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	2874e531-d647-339c-e063-6394a90ac86f	2024-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Sheer Hydration Tinted Moisturizing Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	a951ebe7-7786-38ef-e053-2995a90a70e3	2024-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Expanscience Laboratories d/b/a Mustela	beec926c-35a5-1901-e053-2a95a90ad043	2024-12-02	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 9N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	95d657e5-cf89-48dd-a12e-f9664b131eb9	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	33f42840-92f8-4fa1-86e9-ec0a06d637de	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	20785934-e534-4ea5-8c15-f9669b042153	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e4464601-a9ec-413b-a883-9efe61f2f5b2	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5e7c879c-1e5c-4614-bec1-d363978c3b0d	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5c1f1f09-19fb-4ceb-bb6d-22d51b5733a8	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c8a48759-efac-47ac-972a-c994b6774e20	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	793c18e5-4363-45b0-a184-0b6c69a91b2c	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8a542b3c-c3c0-465a-9b24-6a62016656f3	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15	OCTINOXATE AND TITANIUM DIOXIDE	Bobbi Brown Professional Cosmetics Inc.	b669c36d-4c94-455d-8534-9c3bb024d668	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15	VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15	Bobbi Brown Professional Cosmetics Inc.	eecb05ab-2048-6e8d-e053-2995a90a8280	2024-11-22	Warnings	Exact identifier unii: 15FIX9V2JP
Instant Hand Sanitizeing Wipe	ISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTS	Shandong Yayun Sanitary Products Co., Ltd.	aa0dc01a-2c6b-7402-e053-2a95a90af6a2	2024-11-21	Warnings	Exact identifier unii: 6DC9Q167V3
MILKY MINERAL SUN SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	53834c89-b3b4-4e21-b9f6-19f95e78ba83	2024-11-21	Warnings	Exact identifier unii: 15FIX9V2JP
Covergirl Aquasmooth Broadspectrum SPF 20 All shades	TITANIUM DIOXIDE	Noxell Corporation	952ea869-581e-4503-9f21-a77d061a417d	2024-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
Baby Wipes	PROPYLENE GLYCOL	Shandong Yayun Sanitary Products Co., Ltd.	aeb9a12c-955f-5030-e053-2995a90a2dd6	2024-11-20	Warnings	Exact identifier unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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