Guaifenesin and Codeine Phosphate

Product NDC: 0121-1550
11-digit product format: 001211550
Labeler code: 0121
Product ID: 0121-1550_2175415b-f07e-50a6-e063-6394a90acabe
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Codeine Phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-10-01
Substance: GUAIFENESIN; CODEINE PHOSPHATE
Active strength: 200; 20 mg/10mL; mg/10mL
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: 2026-12-31
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: Guaifenesin and Codeine Phosphate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	200 mg/10mL
CODEINE PHOSPHATE	20 mg/10mL

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
88d0994c-4270-4408-8837-bd97510b2118	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0121-1550-00	2022-03-28	C162847	48780-1	d6a99b39-4ea2-a426-e053-dadaa90af4c2	Guaifenesin and Codeine Phosphate
0121-1550-00	2022-01-28	C162847	48780-1	d6a99b39-4ea2-a426-e053-dadaa90af4c2	Guaifenesin and Codeine Phosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0121-1550-00	Guaifenesin and Codeine Phosphate	10 in 1 TRAY	SOLUTION	10	11
0121-1550-00	Guaifenesin and Codeine Phosphate	10 in 1 CASE	SOLUTION	10	11
0121-1550-10	Guaifenesin and Codeine Phosphate	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	11
0121-1550-40	Guaifenesin and Codeine Phosphate	10 in 1 TRAY	SOLUTION	10	11
0121-1550-40	Guaifenesin and Codeine Phosphate	4 in 1 CASE	SOLUTION	4	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1550-00	ML - Milliliter	0121-1550	b69d5b9d-f7c2-4d33-9f44-67c832179cf2	1	2017-08-11
0121-1550-10	ML - Milliliter	0121-1550	dee23321-cef1-46cb-8d6c-347c5e81ccb6	1	2017-08-11
0121-1550-40	ML - Milliliter	0121-1550	cdc60019-dabf-48fa-90f2-cd3a54928f5d	1	2024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	1
Codeine	ACTIVE MOIETY	Q830PW7520	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1550	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC]	11	Current NDC, Legacy NDC, 5 package rows	20240907_88d0994c-4270-4408-8837-bd97510b2118.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 82 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51dca689-e4a0-5526-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6f2d18f6-935f-9215-e053-2a91aa0aedd3	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6fb28fa1-ebbb-64bf-e053-2991aa0a1de4	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5213ca7f-5a78-6471-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6f7ba256-ed14-5fe0-e053-2a91aa0aacc1	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	6f7bf92d-4aaf-86e0-e053-2991aa0a2d91	2025-12-04	Warnings	Exact identifier application number: M012
Afrin NoDrip Allergy Sinus Night	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	b023a571-7e54-7c63-e053-2a95a90a0f78	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE	Bayer HealthCare LLC.	b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d	2025-12-04	Warnings	Exact identifier application number: M012
Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	e3231869-8ddf-9d17-e053-2995a90ae6d5	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Multi Symptom Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	ae7cf41e-b618-d6bb-e053-2a95a90a6692	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Allergy Sinus Nasal	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	c2d903bf-5c51-82d7-e053-2995a90aea49	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold, Cough and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	351d3c5c-05c8-921a-e063-6394a90abef9	2025-12-04	Warnings	Exact identifier application number: M012
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold Flu And Chest Congestion	ACETAMINOPHEN, GUAIFENESIN	Bayer HealthCare LLC.	de95d2dd-e766-f7ec-e053-2995a90afc5f	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold and Flu Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e4f3f906-2252-21d1-e053-2a95a90a85df	2025-12-04	Warnings	Exact identifier application number: M012
Afrin No Drip Pump Mist Bundle Pack	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	16c52c79-baec-87db-e063-6294a90a3b3b	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	0f5ec576-f788-40aa-9088-0dd672e3cc7c	2025-12-04	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	432a79a9-c69d-4514-894a-7832e1b745ef	2025-12-04	Warnings	Exact identifier application number: M012
GENCONTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	69d16d25-b09b-430e-8e01-0962d840dc21	2025-12-04	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	H E B	7c04ab14-af28-4598-90ef-56ac11902c7d	2025-12-04	Warnings	Exact identifier application number: M012

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

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	88d0994c-4270-4408-8837-bd97510b2118	11
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	88d0994c-4270-4408-8837-bd97510b2118	11
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	88d0994c-4270-4408-8837-bd97510b2118	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-1550-00	00121155000	10 TRAY in 1 CASE (0121-1550-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1550-10)	10 tray	2006-10-01	0000-00-00	No	No	Current
0121-1550-10	00121155010	10 mL in 1 CUP, UNIT-DOSE	10 ml					Historical
0121-1550-40	00121155040	4 TRAY in 1 CASE (0121-1550-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1550-10)	4 tray	2024-01-10		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin and Codeine Phosphate	PAI Holdings, LLC \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-09-06	HUMAN OTC DRUG LABEL	11