NDC 52959-312 - Theracodophen-Low-90

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: 52959-312
Package NDCs from labels: 52959-312-30
Manufacturer: Physician Therapeutics LLC | Amneal Pharmaceuticals, LLC | H.J. Harkins Company, Inc. | Targeted Medical Pharma Inc.
Effective date: 2011-08-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Theracodophen-Low-90	Physician Therapeutics LLC \| Amneal Pharmaceuticals, LLC \| 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
52959-312-30	Theracodophen-Low-90	30 in 1 BOTTLE	TABLET	30	5 mg	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-312	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13	Unmatched	20110812_5dbfb94c-0bbf-4096-baf5-c6690a2d0997.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
CHOLINE BITARTRATE	INACTIVE INGREDIENT	6K2W7T9V6Y	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
CINNAMON	INACTIVE INGREDIENT	5S29HWU6QB	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
COCOA	INACTIVE INGREDIENT	D9108TZ9KG	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
GLUTAMINE	INACTIVE INGREDIENT	0RH81L854J	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
GRAPE	INACTIVE INGREDIENT	6X543N684K	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
THEOBROMINE	INACTIVE INGREDIENT	OBD445WZ5P	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
TRICALCIUM PHOSPHATE	INACTIVE INGREDIENT	K4C08XP666	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13
WHEY	INACTIVE INGREDIENT	8617Z5FMF6	THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	13

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 86 of 285 · 5,684 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BioElectro Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Genomma Lab USA	683a0fba-921c-48e7-a391-180c04f0d1c4	2025-12-30	Warnings	Exact identifier unii: 362O9ITL9D
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE	Pioneer Life Sciences, LLC	0181af13-da32-4431-be39-c31fdfac9202	2025-12-29	Warnings	Exact identifier unii: 362O9ITL9D
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	KROGER	a690f5c5-ff41-4072-e053-2995a90a8e55	2025-12-29	Warnings	Exact identifier unii: 362O9ITL9D
SPF 30 Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	CLEURE	f5512f34-08ee-b0f6-e053-2a95a90ab5bd	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	897b8edb-f089-4a49-baca-e05806b0a068	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
OI LIN SUNMILK SUNSCREEN SPF 30	SUNSCREEN, TITANIUM DIOXIDE	Sunrider Manufacturing L.P.	26b57314-1616-4ca4-b65f-a363c525b432	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry	ACETAMINOPHEN	Puro Pharma Inc.	a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009	2025-12-27	Warnings	Exact identifier unii: 362O9ITL9D
Cystex PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Clarion Brands, LLC	9668a2ca-729e-4172-80b5-33e6c5175ba4	2025-12-27	Warnings	Exact identifier unii: 362O9ITL9D
Nite-Time COLD/FLU Medicine	ACETAMINOPHEN	AptaPharma Inc.	344440bc-d810-4296-93ec-e6ae6673856b	2025-12-26	Warnings	Exact identifier unii: 362O9ITL9D
Nite-Time COLD/FLU Medicine Cherry	ACETAMINOPHEN	AptaPharma Inc.	87c2b823-ed88-44f3-8f6a-df30430b40f3	2025-12-26	Warnings	Exact identifier unii: 362O9ITL9D
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Pioneer Life Sciences, LLC	aa2de3a5-a20d-33c6-e053-2a95a90ada3e	2025-12-26	Warnings	Exact identifier unii: 362O9ITL9D
Childrens Pain and Fever	ACETAMINOPHEN	Discount Drug Mart	2aa0f9f3-924c-4a4a-bb5f-2a326acc2408	2025-12-26	Warnings	Exact identifier unii: 362O9ITL9D
Gencare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	a9875dc9-6a27-413c-a2c7-68a86483ffc1	2025-12-26	Warnings	Exact identifier unii: 362O9ITL9D
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	RedPharm Drug	2c6014de-8901-9d83-e063-6294a90ad37b	2025-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Pharbetol	ACETAMINOPHEN	Pharbest Pharmaceuticals, Inc.	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	2025-12-24	Warnings	Exact identifier unii: 362O9ITL9D
CETAFEN EXTRA	ACETAMINOPHEN	HART Health	38db0b09-37f8-4fed-903e-81e89486b39b	2025-12-24	Warnings	Exact identifier unii: 362O9ITL9D
CETAFEN	ACETAMINOPHEN	HART Health	c1162bab-377d-4e17-9417-ccd20d29148b	2025-12-24	Warnings	Exact identifier unii: 362O9ITL9D
StellaLife VEGA Oral Care	SPRAY	StellaLife, Inc.	b8ba495e-2cfe-092c-e053-2995a90a3fd3	2025-12-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Recovery Kit	KIT	Homeocare Laboratories, Inc.	b701234a-0bd2-16d3-e053-2995a90a5b13	2025-12-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
CETAFEN COUGH and COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,	HART Health	44da0d8c-4a12-4122-99da-781e2809e1a8	2025-12-24	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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