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 146 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	c92b508b-e5f9-4149-8c4b-d21845943b3b	2024-10-22	Warnings	Exact identifier application number: M012
Cold Flu Severe Day Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	2924a691-b352-4263-b6ba-9ab97e95e2a5	2024-10-22	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HARRIS TEETER	b2091281-a64a-190a-e053-2995a90a890a	2024-10-22	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	Safeway	cf04bdf7-fed4-4f06-a193-f2e83fcc531c	2024-10-22	Warnings	Exact identifier application number: M012
Tukol Honey Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	c9572b16-8e28-4f98-bd87-8a07721a49c6	2024-10-21	Warnings	Exact identifier application number: M012
Tukol Honey Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Genomma Lab USA	bf25f38e-3549-4f78-be90-46605b5f2c11	2024-10-21	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HEB	b5a6719e-746b-58ec-e053-2a95a90af010	2024-10-21	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	a6cdc084-c23b-e733-e053-2995a90a3506	2024-10-21	Warnings	Exact identifier application number: M012
Cold Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	ea39a67d-8a99-4f7c-9925-94b07d0b1092	2024-10-21	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	eb7920a3-3c25-6aa1-e053-2995a90ac2b9	2024-10-21	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	9cbb3ab1-5f32-421e-9f28-d99be9447e9f	2024-10-21	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	eb791902-e2c3-5662-e053-2995a90a37fd	2024-10-21	Warnings	Exact identifier application number: M012
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	c3849b66-697f-4f6e-93ab-76de031b3c70	2024-10-21	Warnings	Exact identifier application number: M012
Cold Flu Severe Day Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	ee1477ed-00c4-46ea-bc57-aef214076dc2	2024-10-21	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTH	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	774e8bee-1ab5-4587-82e4-31da8ec83544	2024-10-21	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	b1ba8ade-3441-f243-e053-2995a90a1230	2024-10-21	Warnings	Exact identifier application number: M012
Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	b1ba22ac-c38d-a42e-e053-2995a90a6900	2024-10-21	Warnings	Exact identifier application number: M012
Diphenhydramine HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	25034563-6422-daf6-e063-6394a90af980	2024-10-21	Warnings	Exact identifier application number: M012
Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	198add5f-20b7-75b0-e063-6394a90a6bd4	2024-10-21	Warnings	Exact identifier application number: M012
Tukol Honey Children Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	dae33df8-2294-4242-a25b-2d89d1f63b23	2024-10-18	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