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 28 of 290 · 5,782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength Acetaminophen	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	58840cf4-aceb-c7cf-e063-6294a90a5ff4	2026-06-01	Warnings	Exact identifier unii: 362O9ITL9D
Cough and Runny Nose Childrens Plus	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	TOP CARE (Topco Associates LLC)	6f04bd51-093c-4624-aef3-0145ac387386	2026-06-01	Warnings	Exact identifier unii: 362O9ITL9D
night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H E B	cf31538c-9eee-4c81-80cb-66eecabf0aff	2026-06-01	Warnings	Exact identifier unii: 362O9ITL9D
Good Sense Pain Relief	ACETAMINOPHEN	L. Perrigo Company	cb5f6008-6884-402a-8a19-c8d585576d63	2026-06-01	Warnings	Exact identifier unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	380ff458-d5d7-422e-ac96-e9a56ade16b6	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: NO70W886KK unii: 362O9ITL9D
Childrens Pain and Fever	ACETAMINOPHEN	CVS Pharmacy	832acd72-1dda-4490-978f-5f31748942df	2026-06-01	Warnings	Exact identifier unii: 362O9ITL9D
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	294e6049-12b5-4b45-ae00-8ee1d9d2a1a4	2026-05-29	Warnings	Exact identifier unii: 15FIX9V2JP
Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	786dbcd5-f5c2-4491-e053-2991aa0a3437	2026-05-29	Warnings	Exact identifier unii: 362O9ITL9D
Hysingla ER	HYDROCODONE BITARTRATE	Knoa Pharma LLC	b7d23ac2-e776-9f62-3290-c64c2d6eb353	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: NO70W886KK
Cold and Flu Day	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	ebf8c82d-a653-4c02-893b-61704901acbb	2026-05-29	Warnings	Exact identifier unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Rhodes Pharmaceuticals LLC	1f9c1adc-f84f-43de-af5c-d93703aba7f8	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: NO70W886KK unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	65c5abc7-520a-4267-acb6-ea6204a3ecfa	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: NO70W886KK unii: 362O9ITL9D
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	5460a4b7-5da3-4fc2-a565-0b0dd11bbf44	2026-05-29	Warnings	Exact identifier unii: 362O9ITL9D
Extra Strength Mini Softgels Pain Reliever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f55d3663-7007-41cd-ae2d-5aca6311be81	2026-05-28	Warnings	Exact identifier unii: 362O9ITL9D
Kids Multi Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Genexa Inc.	2d918ec8-3098-1d09-e063-6294a90a9e8f	2026-05-28	Warnings	Exact identifier unii: 362O9ITL9D
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5130c695-a80e-2dd3-e063-6294a90a404f	2026-05-28	Warnings	Exact identifier unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Eywa Pharma Inc	1da85ac1-46a2-4081-b533-4890ec9e0482	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Select Consumer Group LLC	52c5fda0-c358-72e8-e063-6394a90a3f68	2026-05-27	Warnings	Exact identifier unii: 362O9ITL9D
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	1622f694-4d63-4c56-8737-fae31f0ecfb7	2026-05-27	Warnings	Exact identifier unii: 362O9ITL9D
Childrens Delsym Cough Plus Cold Night Time	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	00689aa5-ed39-4c9a-92b8-105d2c0e2e15	2026-05-27	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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