Codeine-Guaifenesin

Product NDC: 58657-500
11-digit product format: 586570500
Labeler code: 58657
Product ID: 58657-500_4e6980b2-573c-2636-e063-6294a90ac0f4
Type: HUMAN OTC DRUG
Nonproprietary name: Codeine Phosphate and Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: Method Pharmaceuticals, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-04-01
Substance: CODEINE PHOSPHATE; GUAIFENESIN
Active strength: 10; 100 mg/5mL; mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Codeine-Guaifenesin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CODEINE PHOSPHATE	10 mg/5mL
GUAIFENESIN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GSL05Y1MN6	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995868	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fe126254-6ee6-48c3-965c-96e4276a5314	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
e9576821-a971-5261-628e-82ad9e10acdb	Product name	2	20150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
58657-500-04	2020-02-11	Codeine-Guaifenesin Oral Solution
58657-500-04	2020-02-11	Codeine-Guaifenesin Oral Solution
58657-500-04	2020-02-11	Codeine-Guaifenesin Oral Solution
58657-500-16	2020-02-11	Codeine-Guaifenesin Oral Solution
58657-500-16	2020-02-11	Codeine-Guaifenesin Oral Solution
58657-500-16	2020-02-11	Codeine-Guaifenesin Oral Solution
58657-500-04	2020-01-31	Codeine-Guaifenesin Oral Solution
58657-500-04	2020-01-31	Codeine-Guaifenesin Oral Solution
58657-500-04	2020-01-31	Codeine-Guaifenesin Oral Solution
58657-500-16	2020-01-31	Codeine-Guaifenesin Oral Solution
58657-500-16	2020-01-31	Codeine-Guaifenesin Oral Solution
58657-500-16	2020-01-31	Codeine-Guaifenesin Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58657-500-04	Codeine-Guaifenesin	120 mL in 1 BOTTLE	SOLUTION	120		16
58657-500-16	Codeine-Guaifenesin	473 mL in 1 BOTTLE	SOLUTION	473		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-500-04	ML - Milliliter	58657-500	165585be-2a2d-4c03-b517-ef66f56bcc4a	1	2014-07-02
58657-500-16	ML - Milliliter	58657-500	b91df96f-0171-473c-9a97-463f578234c3	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58657-500	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]	14	Current NDC, Legacy NDC, 2 package rows	20241126_fe126254-6ee6-48c3-965c-96e4276a5314.zip

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 163 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Plus Multi Symptom Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	dd967cfb-96b4-4cdc-82e2-a4838001c9e3	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Wal Tap Elixer Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreens	3f438f28-d1ad-44da-a573-f1b0824b051c	2024-05-08	Warnings	Exact identifier application number: M012
Cough Cold and Sore Throat Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	400a0998-e276-4c8d-9b41-145b1b405fff	2024-05-08	Warnings	Exact identifier application number: M012
Mucus Congestion and Cough Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI	Walgreens	19cd2409-d56b-4319-833c-eacc7dc498c1	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b12f0e-dba7-fd71-e063-6294a90a42c1	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE	Kroger	10b15337-b9c5-4dc8-e063-6394a90ac056	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger	1014da86-3a0e-136f-e063-6294a90ac931	2024-05-04	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	eaa10aed-5b1e-48bf-bc05-7a5638851daf	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	e35cb719-9e7d-4b2b-81a4-29e147dd74fa	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	09e20842-2b75-43b9-ae5f-3515b35e655b	2024-05-03	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	f958d8ba-ede9-4b1a-8317-2404b68a9129	2024-05-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WinCo Foods, LLC	fab57d70-ba54-416f-9f14-b64d2238ea16	2024-05-03	Warnings	Exact identifier application number: M012
Tussin CF Non Drowsy Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	8ee27600-4f8e-406a-8ea3-eade691448f6	2024-05-03	Warnings	Exact identifier application number: M012
SanaTos Children Cough and Congestion Cherry	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Pharmadel LLC	60437d86-9e13-8d8a-e053-2991aa0a2317	2024-05-02	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	0b41da13-18a1-4987-ae43-1319bfa27484	2024-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a	2024-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	dbfb8971-a122-4a97-a665-e3f0d494876e	2024-05-01	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	c08b150c-d821-466c-8521-f77535d6af1e	2024-04-30	Warnings	Exact identifier application number: M012
childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	7848bb09-2af8-47f6-b32d-96635a750a55	2024-04-29	Warnings	Exact identifier application number: M012
NASAL and SINUS DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	JHK Inc dba American Safety & First Aid	63e51305-2575-49c4-9fda-7b3e1b4b6ede	2024-04-26	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	9812056b-736e-40c5-ae60-21dd9221397c	100
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	9812056b-736e-40c5-ae60-21dd9221397c	100
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	9812056b-736e-40c5-ae60-21dd9221397c	100
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	fe126254-6ee6-48c3-965c-96e4276a5314	16
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	fe126254-6ee6-48c3-965c-96e4276a5314	16
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	fe126254-6ee6-48c3-965c-96e4276a5314	16
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	fdfb2d26-f4e1-4559-9db4-12e28bd916b6	4
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	fdfb2d26-f4e1-4559-9db4-12e28bd916b6	4
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	fdfb2d26-f4e1-4559-9db4-12e28bd916b6	4
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	9e691264-d48a-6b48-e053-2995a90a9352	3
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	9e691264-d48a-6b48-e053-2995a90a9352	3
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	9e691264-d48a-6b48-e053-2995a90a9352	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58657-500-04	58657050004	120 mL in 1 BOTTLE (58657-500-04)	120 ml	2014-04-01	0000-00-00	No	No	Current
58657-500-16	58657050016	473 mL in 1 BOTTLE (58657-500-16)	473 ml	2014-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Codeine-Guaifenesin Oral Solution	Method Pharmaceuticals, LLC	2026-04-01	HUMAN OTC DRUG LABEL	16
Codeine-Guaifenesin Oral Solution	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN OTC DRUG LABEL	3
Codeine-Guaifenesin Oral Solution	Bryant Ranch Prepack	2024-03-22	HUMAN OTC DRUG LABEL	100
Codeine-Guaifenesin Oral Solution	Preferred Pharmaceuticals Inc.	2022-12-12	HUMAN OTC DRUG LABEL	5
Codeine-Guaifenesin Oral Solution	ATLANTIC BIOLOGICALS CORP.	2021-01-26	HUMAN OTC DRUG LABEL	4
Codeine-Guaifenesin Oral Solution	Quality Care Products, LLC	2019-04-24	HUMAN OTC DRUG LABEL	1