NDC 0031-2231 - Dimetapp

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0031-2231
Package NDCs from labels: 0031-2231-89, 0031-2231-86, 0031-2231-88
Manufacturer: Haleon US Holdings LLC
Effective date: 2024-04-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Dimetapp - Haleon US Holdings LLC	Haleon US Holdings LLC	2024-04-24	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0031-2231-86	Dimetapp	1 in 1 CARTON	ELIXIR	1	6
0031-2231-86	Dimetapp	118 mL in 1 BOTTLE	ELIXIR	118	6
0031-2231-88	Dimetapp	118 mL in 1 BOTTLE	ELIXIR	118	6
0031-2231-88	Dimetapp	1 in 1 CARTON	ELIXIR	1	6
0031-2231-89	Dimetapp	118 mL in 1 BOTTLE	ELIXIR	118	6
0031-2231-89	Dimetapp	1 in 1 CARTON	ELIXIR	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-2231	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [HALEON US HOLDINGS LLC]	6	6 package rows	20240426_4f7b773b-950f-41fb-b024-689a89019fda.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]	1

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 11 of 28 · 553 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Ohm Laboratories Inc.	87ab4578-84de-475d-a4b0-eec969f17253	2025-11-13	Warnings	Exact identifier unii: 6V9V2RYJ8N
Eyesaline Eyewash Concentrate	PURIFIED WATER	Honeywell Safety Products USA, Inc.	3765c251-eb14-d60f-e063-6294a90a6a4d	2025-11-12	Warnings	Exact identifier unii: 059QF0KO0R
Eyesaline Emergency Eyewash	PURIFIED WATER	Honeywell Safety Products USA, Inc.	37f244fd-c02f-e66a-e063-6394a90aed81	2025-11-12	Warnings	Exact identifier unii: 059QF0KO0R
AQUACETIC-30	CLEANING SOLUTION FOR HEMODIALYSIS MACHINES	Aqua Medica, S.A. de C.V.	040775ab-41bd-cd36-e063-6394a90a08aa	2025-11-10	Warnings	Exact identifier unii: 2968PHW8QP
CITRACID-50	DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINE	Aqua Medica, S.A. de C.V.	040713e7-67cd-8eb0-e063-6394a90aa2a9	2025-11-10	Warnings	Exact identifier unii: 2968PHW8QP
TARGET Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	TARGET CORPORATION	bfc91c71-0506-4e94-8bfe-dc9e4bf959da	2025-11-07	Warnings	Exact identifier unii: IXA7C9ZN03
CHILDRENS COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	H E B	08f4785a-c628-4e9b-9412-b2a817f9be60	2025-11-07	Warnings	Exact identifier unii: IXA7C9ZN03
STERILE WATER	WATER	Henry Schein, Inc.	f4087143-9868-4308-b96c-43657ee8ec28	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sinus Congestion	PSEUDOEPHEDRINE HCL	Chain Drug Marketing Association, Inc.	9744d04d-298d-4acd-9470-db9e7f2901e7	2025-11-07	Warnings	Exact identifier unii: 6V9V2RYJ8N
TARGET CHILDRENs COLD and COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	eb912834-1b14-484d-90f7-a8deb52c0d4e	2025-11-05	Warnings	Exact identifier unii: IXA7C9ZN03
Bacteriostatic Water	BACTERIOSTATIC WATER	ProPharma Distribution	42c6938e-f747-ae13-e063-6294a90a59a3	2025-11-04	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	ICU Medical Inc.	aab10f03-26ae-4dbc-a481-ef025e48b405	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	ICU Medical Inc.	e3484bc6-ed7f-43ef-9d49-c131a8dff2dd	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
SudoGest 12 Hour	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	e829aab0-3ef0-4149-8197-96c5ce0b31d2	2025-10-30	Warnings	Exact identifier unii: 6V9V2RYJ8N
Good Sense Suphedrine 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	1de8a7f6-e7bb-437d-8794-c4b9f43b89c9	2025-10-30	Warnings	Exact identifier unii: 6V9V2RYJ8N
Sorbitol-Mannitol	SORBITOL AND MANNITOL	ICU Medical Inc.	5b44e248-4b7b-4777-954a-921c7b309944	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 506T60A25R
Sterile Water	WATER	ICU Medical Inc.	1c0bbcb7-5ed6-4ee7-b297-080d3359474e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Bacteriostatic Water	WATER	Henry Schein, Inc.	a833502e-a622-4e81-8c58-cef6ccb6c4c9	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Guaifenesin and Pseudoephedrine HCL	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Dr. Reddys Laboratories Limited	845a2dcc-9069-3141-ae13-f2063f36d130	2025-10-24	Warnings	Exact identifier unii: 6V9V2RYJ8N
Sterile Water	WATER	Becton Dickinson and Company	cab03cda-4660-4020-a3be-bf86242ff664	2025-10-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.