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 101 of 114 · 2,263 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4935f888-cd92-61d1-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
Coral Safe SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4925a507-863f-1088-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
CoralSafe Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands	e6e00896-b7e5-41c6-a72b-08e600758cf5	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
Coral Safe SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4925a3ad-6379-108a-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	fb677ad0-2791-44ec-9720-951471ec009a	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Shaklee Youth Age Defense Mineral Moisturizer SPF 30	TITANIUM DIOXIDE	Shaklee Corporation	f4888fdc-09f9-43de-8c81-5a0f5e767d4e	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Spit and Polish Sun Smart Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Naturally Uncommon, LLC	af879a05-1483-5c11-e053-2995a90af45d	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
EltaMD UV Active	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc.	2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd2	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Physical Sunscreen SPF50 80 min WR 159-100	TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN	Swiss-American CDMO, LLC	0cca7b65-e24a-429c-b157-5f4e343424ab	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a20dc51a-1f6c-4a6d-97f6-2f048e0689a0	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a6c8b20f-6377-443b-a89b-8b5d40c65ad8	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	b6591b2e-9e55-4f25-958c-f36f1ef85749	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	6e2ae7cb-c390-4996-95e8-ae8fadefa8bd	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a143c8cb-185c-4fd8-a901-3c0d9ffb8290	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	3d6e438d-9ea4-4253-9153-748d3c974265	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	173aeaab-a286-48ed-9033-10b13f547bbd	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	d877575a-25f3-49bd-b403-ecf6a1eb483a	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	24e1e576-9edd-45aa-a883-2a2d18a1cb5e	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a8fffe38-5f90-4078-b553-30036659a2ee	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	bfa2b2be-958c-439f-b363-2623df2b8501	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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