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 53 of 286 · 5,717 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sedalmex XL Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Belmora LLC	f2edfedf-e06e-4d1b-8c2d-732e08ec113c	2026-03-19	Warnings	Exact identifier unii: 362O9ITL9D
DUAL ACTION BACK PAIN RELIEVER	ACETAMINOPHEN, IBUPROFEN	Meijer, Inc.	8d9a0c56-ef22-45a6-8b1d-d2b2f3247210	2026-03-19	Warnings	Exact identifier unii: 362O9ITL9D
Extra Strength Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	ea417ddb-54b3-49e2-bec1-8fe450d9990c	2026-03-19	Warnings	Exact identifier unii: 362O9ITL9D
Premier Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Premier Plastic Surgery	4d3a36b9-7d60-01ac-e063-6294a90af4fb	2026-03-18	Warnings	Exact identifier unii: 15FIX9V2JP
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	29491adb-d95d-4f68-ac01-61bad73e08fc	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: NO70W886KK unii: 362O9ITL9D
CHILDRENS PAIN AND FEVER	ACETAMINOPHEN	HyVee Inc	3b08738e-cde2-4843-b609-8f12582c6d08	2026-03-18	Warnings	Exact identifier unii: 362O9ITL9D
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Salado Sales, Inc.	0666f082-84f3-4041-a322-311188a15670	2026-03-18	Warnings	Exact identifier unii: 362O9ITL9D
AMAZON BASICS ACETAMINOPHEN	ACETAMINOPHEN	Amazon.com Services LLC	3c2914a4-913e-7e50-e063-6294a90aff3a	2026-03-18	Warnings	Exact identifier unii: 362O9ITL9D
BUTALBITAL AND ACETAMINOPHEN	BUTALBITAL AND ACETAMINOPHEN	Amici Pharma, Inc.	3280501f-928a-4112-803d-fb9771c86547	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Otoflam HP	BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLA	BioActive Nutritional, Inc.	12f1ef62-93f3-45b8-885d-1b82f85a8355	2026-03-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Grocery Outlet	7398a372-7679-423b-a3ca-8da905a979dd	2026-03-17	Warnings	Exact identifier unii: 362O9ITL9D
OSKIN New York Coffee BB Cream SPF 30	TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE	O'Skin Studio NY	29dae75a-4368-432a-9cf8-f0f021f09e29	2026-03-17	Warnings	Exact identifier unii: 15FIX9V2JP
Premier Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Premier Plastic Surgery	4d39b64c-2e27-afed-e063-6394a90a3812	2026-03-17	Warnings	Exact identifier unii: 15FIX9V2JP
Powder	TITANIUM DIOXIDE	Oxygen Development LLC	4d39ed7a-ca80-893c-e063-6294a90a03e7	2026-03-17	Warnings	Exact identifier unii: 15FIX9V2JP
Powder	TITANIUM DIOXIDE	Oxygen Development LLC	4d3a0a92-b0de-a1ea-e063-6294a90a8508	2026-03-17	Warnings	Exact identifier unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Derma Care Research Labs, LLC	0aafab44-0481-2a22-e063-6294a90abef2	2026-03-17	Warnings	Exact identifier unii: 15FIX9V2JP
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Summer Friday's LLC	4d3e982f-3489-dce2-e063-6294a90a1b9d	2026-03-17	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream	410 N	Melaleuca Inc.	2f380433-3369-9d05-e063-6394a90a6479	2026-03-17	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream	115 N	Melaleuca Inc.	2f132cc0-e8e3-35e3-e063-6394a90a4f3d	2026-03-17	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Sunscreen Broad SPF30	TINTED SUNSCREEN BROAD SPF30	DOSCHER FAMILY HEALTH NP P.C.	4d4021ba-4b29-6b81-e063-6294a90a5ea7	2026-03-17	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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