Guaifenesin and Codeine Phosphate

Product NDC: 0121-0775
11-digit product format: 001210775
Labeler code: 0121
Product ID: 0121-0775_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: 100; 10 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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0121-0775	0121-0775-08	D	Discontinued by firm		2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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	100 mg/5mL
CODEINE PHOSPHATE	10 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
88d0994c-4270-4408-8837-bd97510b2118	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
0121-0775-04	2022-03-28	Guaifenesin and Codeine Phosphate
0121-0775-08	2022-03-28	Guaifenesin and Codeine Phosphate
0121-0775-16	2022-03-28	Guaifenesin and Codeine Phosphate
0121-0775-04	2022-01-28	Guaifenesin and Codeine Phosphate
0121-0775-08	2022-01-28	Guaifenesin and Codeine Phosphate
0121-0775-16	2022-01-28	Guaifenesin and Codeine Phosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0121-0775-04	Guaifenesin and Codeine Phosphate	118 mL in 1 BOTTLE	SOLUTION	118	11
0121-0775-08	Guaifenesin and Codeine Phosphate	237 mL in 1 BOTTLE	SOLUTION	237	11
0121-0775-16	Guaifenesin and Codeine Phosphate	473 mL in 1 BOTTLE	SOLUTION	473	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0775-04	ML - Milliliter	0121-0775	ac9f8c15-4f02-4667-b975-5c20f7d93dab	1	2012-07-24
0121-0775-08	ML - Milliliter	0121-0775	ef3933a2-ccb0-4b44-977e-b6b8f9f14e12	1	2018-02-20
0121-0775-16	ML - Milliliter	0121-0775	270b5b4b-ceb0-4155-ad98-6b3454cf2a29	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	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
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
CITRIC ACID ACETATE	INACTIVE INGREDIENT	DSO12WL7AU	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0775	GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC]	11	Current NDC, Legacy NDC, 3 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 66 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Winco Foods Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	WinCo Foods, LLC	f54eb60d-c602-1272-e053-2995a90aa95a	2025-12-28	Warnings	Exact identifier application number: M012
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	ad4d74a8-a762-4378-9016-f7c83421073e	2025-12-26	Warnings	Exact identifier application number: M012
Sorbutuss NR	SORBUTUSS	Dextrum Laboratories Inc.	304f1d5a-218c-51ae-e054-00144ff88e88	2025-12-26	Warnings	Exact identifier application number: M012
caring mill Cough drops CHERRY	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	274a28aa-00e9-8b9d-e063-6394a90ace2a	2025-12-26	Warnings	Exact identifier application number: M012
Creamy Strawberry Flavor Cough Drop	CREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2749b83a-ea4f-d8ca-e063-6394a90a69b7	2025-12-26	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS CHERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f4a026-c4d2-2645-e063-6294a90aac58	2025-12-26	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	274a13b5-6fcb-70ed-e063-6394a90a7fb3	2025-12-26	Warnings	Exact identifier application number: M012
Honey Lemon Flavor Cough Drop	HONEY LEMON FLAVOR COUGH DROP	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	274a4802-7c02-ccce-e063-6394a90ad71d	2025-12-26	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS HONEY LEMON	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2749f353-9286-15b9-e063-6394a90a7693	2025-12-26	Warnings	Exact identifier application number: M012
Leader Cough Drops Vanilla Honey	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	26a93c2c-a663-e3d1-e063-6394a90ad859	2025-12-26	Warnings	Exact identifier application number: M012
Nite-Time COLD/FLU Medicine	ACETAMINOPHEN	AptaPharma Inc.	344440bc-d810-4296-93ec-e6ae6673856b	2025-12-26	Warnings	Exact identifier application number: M012
Nite-Time COLD/FLU Medicine Cherry	ACETAMINOPHEN	AptaPharma Inc.	87c2b823-ed88-44f3-8f6a-df30430b40f3	2025-12-26	Warnings	Exact identifier application number: M012
TUSSIN CF	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	AptaPharma Inc.	c005c6cf-7891-463e-b65d-1129ad4bf6ec	2025-12-26	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	AptaPharma Inc.	b2cef61f-ab54-4a20-a7f7-6d3da4754e8b	2025-12-26	Warnings	Exact identifier application number: M012
CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	AptaPharma Inc.	9ae6fe74-80cd-482a-b3b9-3acafd6708ec	2025-12-26	Warnings	Exact identifier application number: M012
Tussin Expectorant	GUAIFENESIN	AptaPharma, Inc.	ca8fa216-09c1-42b2-a95b-fa3d0f13363c	2025-12-26	Warnings	Exact identifier application number: M012
Gencare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	a9875dc9-6a27-413c-a2c7-68a86483ffc1	2025-12-26	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	3b7e0ee7-4dda-4bbe-842c-6cbbc208acd5	2025-12-26	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f	2025-12-26	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG	Pioneer Life Sciences, LLC	3ce0f096-906e-47eb-8061-0ac1e9d8ea55	2025-12-26	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
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	36140639-e7a8-43bc-83e2-469430af9d1a	9
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	36140639-e7a8-43bc-83e2-469430af9d1a	9
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	36140639-e7a8-43bc-83e2-469430af9d1a	9
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	f5265ae5-db8e-428d-90e9-5eda6a8a22bd	3
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	f5265ae5-db8e-428d-90e9-5eda6a8a22bd	3
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	f5265ae5-db8e-428d-90e9-5eda6a8a22bd	3
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	91e9e5e2-5178-4476-9333-02c27bfc4f70	1
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	9f130e16-c588-43be-bb19-e30d2268e527	1
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	f27dcda2-e7a2-469a-9649-12c065cb7459	1
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	91e9e5e2-5178-4476-9333-02c27bfc4f70	1
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	9f130e16-c588-43be-bb19-e30d2268e527	1
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	f27dcda2-e7a2-469a-9649-12c065cb7459	1
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	9f130e16-c588-43be-bb19-e30d2268e527	1
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	f27dcda2-e7a2-469a-9649-12c065cb7459	1
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	91e9e5e2-5178-4476-9333-02c27bfc4f70	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0775-04	00121077504	118 mL in 1 BOTTLE (0121-0775-04)	118 ml	2006-10-01	0000-00-00	No	No	Current
0121-0775-08	00121077508	237 mL in 1 BOTTLE (0121-0775-08)	237 ml	2006-10-01	0000-00-00	No	No	Current
0121-0775-16	00121077516	473 mL in 1 BOTTLE (0121-0775-16)	473 ml	2006-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin and Codeine Phosphate	Preferred Pharmaceuticals Inc.	2026-09-29	HUMAN OTC DRUG LABEL	4
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
Guaifenesin and Codeine Phosphate	A-S Medication Solutions	2024-02-13	HUMAN OTC DRUG LABEL	9
Guaifenesin and Codeine Phosphate	NuCare Pharmaceuticals,Inc.	2021-02-10	HUMAN OTC DRUG LABEL	4
Guaifenesin and Codeine Phosphate	RPK Pharmaceuticals, Inc.	2020-12-23	HUMAN OTC DRUG LABEL	1
Guaifenesin and Codeine Phosphate	REMEDYREPACK INC.	2020-11-16	HUMAN OTC DRUG LABEL	2
Guaifenesin and Codeine Phosphate	Preferred Pharmaceuticals Inc.	2020-02-07	HUMAN OTC DRUG LABEL	1
Guaifensin and Codeine Phosphate Oral Solution USP CV	Proficient Rx LP	2019-12-01	HUMAN OTC DRUG LABEL	2
GUAIFENESIN AND CODEINE PHOSPHATE	DirectRX	2015-10-26	HUMAN OTC DRUG LABEL	1
Guaifensin and Codeine Phosphate Oral Solution USP CV	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-06-18	HUMAN OTC DRUG LABEL	1