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 175 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freegells Cough Drops Menthol Honey Lemon	MENTHOL	Riclan S.A.	f6271e85-9ca2-41d3-9bff-a13670ac5b80	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Strawberry	MENTHOL	Riclan S.A.	da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457	2023-10-26	Warnings	Exact identifier application number: M012
DG Health Cough Drops Assorted Flavors	MENTHOL	Dollar General Corporation	c731d255-40f2-3cb3-e053-2a95a90a8877	2023-10-26	Warnings	Exact identifier application number: M012
ALKA SELTZER PLUS Cold Day and Night Effervescent	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Sincronia Logistica, S.A. de C.V.	c478df69-823a-4112-8f44-323249a9f38f	2023-10-23	Warnings	Exact identifier application number: M012
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	P & L Development, LLC	169006cb-7dc2-4113-a289-0b1f14e784b7	2023-10-23	Warnings	Exact identifier application number: M012
Night-Time Cold and Flu Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	HealthLife of USA	2ffd62a6-703f-4cb0-bb13-49719c004d00	2023-10-21	Warnings	Exact identifier application number: M012
Day-Time Cold and Flu Relief	ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN	HealthLife of USA	c5f6cf22-2aaa-40e1-b7b3-448e55898d62	2023-10-21	Warnings	Exact identifier application number: M012
PENTREXCILINA	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Healthlife of USA	ae9ada14-0ec8-4c01-a874-237f2108936a	2023-10-21	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	APNAR PHARMA LP	e5004c10-3877-c199-e053-2a95a90aa8ac	2023-10-21	Boxed warning, Warnings	Exact identifier application number: M012
Day and Night Multi Symptom Cold and Flu Relief	DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF	Intrivo Diagnostics Inc.	a311bf39-de6c-4ed5-949e-718ad8be1e49	2023-10-13	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0d65c4a9-938c-4a89-b1f1-d9ada8a8c587	2023-10-10	Warnings	Exact identifier application number: M012
Triacting Daytime Cold Cough Childrens	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8656aa2e-9546-4de4-9ecc-ce99bf903333	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL	Walgreens	a33ae35b-1cde-4a3d-a836-3b169e4f1bb9	2023-10-10	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	553d01a9-e8ad-4797-b55b-32f134f08af9	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief Maximum StrengthCold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	8781e2c5-ad46-4615-a0d9-879590e86f95	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	419df833-1f33-45cf-bab3-730c928d5887	2023-10-10	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	93a5cb36-3262-4224-a5be-5ea1619a67bd	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	CVS Pharmacy	782fb103-cd9f-4e8c-8f3a-1fb131b9eda6	2023-10-09	Warnings	Exact identifier application number: M012
Cold and Congestion Childrens Nighttime	DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL	Walgreens	a7847413-e556-4f88-8a7f-a8528afbe927	2023-10-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	06d2c6cf-0adb-91b9-e063-6294a90aff52	2023-10-03	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