Codeine-Guaifenesin

Product NDC: 69367-272
11-digit product format: 693670272
Labeler code: 69367
Product ID: 69367-272_447eca2f-cbca-4ae6-bcd9-dfac47105319
Type: HUMAN OTC DRUG
Nonproprietary name: Codeine Phosphate and Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-07-15
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

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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69367-272-04	Codeine-Guaifenesin	118 mL in 1 BOTTLE	SOLUTION	118		6
69367-272-16	Codeine-Guaifenesin	473 mL in 1 BOTTLE	SOLUTION	473		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69367-272	CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [WESTMINSTER PHARMACEUTICALS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250515_3da3efd7-e278-4d79-9130-eef3992097e4.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 171 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banophen	DIPHENHYDRAMINE HCL	A-S Medication Solutions	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	2024-01-08	Warnings	Exact identifier application number: M012
AXIM DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	0e7424ea-461f-5ead-e063-6294a90a41b6	2024-01-05	Warnings	Exact identifier application number: M012
AXIM Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	0e740063-80d5-c48b-e063-6394a90a3b30	2024-01-05	Warnings	Exact identifier application number: M012
AXIM DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	0e742e10-daea-6443-e063-6294a90ab5af	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	A-S Medication Solutions	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	2024-01-04	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE 10mg	PHENYLPHRINE HCL	YYBA CORP	05824fc4-ef3f-4ebb-b601-252f76ad60ef	2024-01-03	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	5943d975-77e4-4cbd-b2d9-d699052fe82a	2024-01-01	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Proficient Rx LP	ac79a7dd-c26e-47d2-8fb9-768d2d09e507	2024-01-01	Warnings	Exact identifier application number: M012
Oxymethazoline HCL	OXYMETHAZOLINE HCL	Proficient Rx LP	96883e5f-18b5-4c1c-b984-756cb86be6ff	2024-01-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	2024-01-01	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	9e067482-8735-4476-a82e-438dd24d4289	2024-01-01	Warnings	Exact identifier application number: M012
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	94e02be4-b8a6-422a-8f66-e6a69e924b2c	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE	AptaPharma Inc.	8a4c55d0-c472-4e89-9fdb-17ecf0af4856	2023-12-30	Warnings	Exact identifier application number: M012
XL-3 Xtreme	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AptaPharma Inc.	dff79e0b-edf0-4dd3-a722-fd9beecd6293	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Salado Sales, Inc.	e25727d0-7dd7-4ef5-b064-7938679f075f	2023-12-29	Warnings	Exact identifier application number: M012
Maximum Strength DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	bb56d09d-ecb0-469e-a16f-f9f1a48942a8	2023-12-29	Warnings	Exact identifier application number: M012
Childrens Cough Mucus Relief	DEXTROMETHORPHANN HBR, GUAIFENESIN	Discount Drug Mart	2c27aca4-e1e2-419a-84c4-857718ca49da	2023-12-29	Warnings	Exact identifier application number: M012
Night Time Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	de2b2e34-62a5-451f-ab68-531d1c9d4d82	2023-12-29	Warnings	Exact identifier application number: M012
H E B MAX SEVERE CONGESTION and COUGH Maxium Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	d2b016ee-5329-45bf-9d71-d626204169cf	2023-12-29	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	3da3efd7-e278-4d79-9130-eef3992097e4	6
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	3da3efd7-e278-4d79-9130-eef3992097e4	6
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	3da3efd7-e278-4d79-9130-eef3992097e4	6
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	c26da6e0-ab1c-46c2-acf5-0074958c03cd	5
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	c26da6e0-ab1c-46c2-acf5-0074958c03cd	5
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	c26da6e0-ab1c-46c2-acf5-0074958c03cd	5
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	e9705358-3522-46b3-a860-afb9141968b4	3
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	e9705358-3522-46b3-a860-afb9141968b4	3
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	e9705358-3522-46b3-a860-afb9141968b4	3
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d	2
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	c6a42780-9977-708f-e053-2a95a90a07e6	2
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d	2
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	c6a42780-9977-708f-e053-2a95a90a07e6	2
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d	2
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	c6a42780-9977-708f-e053-2a95a90a07e6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69367-272-04	69367027204	118 mL in 1 BOTTLE (69367-272-04)	118 ml	2020-07-15	0000-00-00	No	No	Current
69367-272-16	69367027216	473 mL in 1 BOTTLE (69367-272-16)	473 ml	2020-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Codeine-Guaifenesin	Westminster Pharmaceuticals, LLC	2026-09-29	HUMAN OTC DRUG LABEL	7
Codeine-Guaifenesin	A-S Medication Solutions	2026-03-31	HUMAN OTC DRUG LABEL	5
Codeine-Guaifenesin	Proficient Rx LP	2024-10-01	HUMAN OTC DRUG LABEL	2
Codeine-Guaifenesin	ATLANTIC BIOLOGICALS CORP. \| UNIT DOSE SOLUTIONS	2024-05-08	HUMAN OTC DRUG LABEL	3
Codeine-Guaifenesin	NuCare Pharmaceuticals,Inc.	2023-06-07	HUMAN OTC DRUG LABEL	2
CODEINE-GUAIFENESIN	Direct Rx	2022-03-07	HUMAN OTC DRUG LABEL	1