Cough DM

Product NDC: 11822-0384
11-digit product format: 118220384
Labeler code: 11822
Product ID: 11822-0384_2f3754c3-078f-479f-ba1b-5d006f9fcd2a
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan polistirex
Dosage form: SUSPENSION
Route: ORAL
Labeler: Rite Aid Corporation
Application: ANDA091135
Marketing category: ANDA
Marketing start: 2012-08-27
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 30 mg/5mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11822-0384		D	Discontinued by firm	2026-10-15
excluded package	package	11822-0384	11822-0384-1	D	Discontinued by firm	2026-10-15
excluded package	package	11822-0384	11822-0384-2	D	Discontinued by firm	2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091135-001	DEXTROMETHORPHAN POLISTIREX	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL			2012-05-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11822-0384-1	Cough DM	1 in 1 CARTON	SUSPENSION	1	7
11822-0384-1	Cough DM	89 mL in 1 BOTTLE	SUSPENSION	89	7
11822-0384-2	Cough DM	148 mL in 1 BOTTLE	SUSPENSION	148	7
11822-0384-2	Cough DM	1 in 1 CARTON	SUSPENSION	1	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
POLISTIREX	INACTIVE INGREDIENT	5H9W9GTW27	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
SODIUM POLYSTYRENE SULFONATE	INACTIVE INGREDIENT	1699G8679Z	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
TRAGACANTH	INACTIVE INGREDIENT	2944357O2O	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0384	COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]	6	Legacy NDC, 4 package rows	20240913_eeec30fa-f534-40f9-a71d-5dae570bbbb3.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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	5b7c2306-ad87-48b0-99b7-71427907db0c	2021-03-23	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
basic care cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	a0f35883-9dd3-49e7-87ac-ce04561ad6c3	2021-03-09	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
equate cough dm	DEXTROMETHORPHAN POLISTIREX	Wal-Mart Stores Inc	5f72c4ad-1c30-41ea-b39c-7f4bb3deced6	2020-07-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	CVS Pharmacy	956f0bd4-3266-4754-9bd2-ac480e3bcbce	2020-05-27	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
CareOne Cough DM	DEXTROMETHORPHAN POLISTIREX	American Sales Company	42f67a3c-8cd7-44a6-8e54-08fb8449e8d7	2019-12-09	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373045	dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	eeec30fa-f534-40f9-a71d-5dae570bbbb3	7
1373045	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension	SCD	eeec30fa-f534-40f9-a71d-5dae570bbbb3	7
1373045	dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension	SY	eeec30fa-f534-40f9-a71d-5dae570bbbb3	7
1373045	dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension	SY	eeec30fa-f534-40f9-a71d-5dae570bbbb3	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0384-1	11822038401	1 BOTTLE in 1 CARTON (11822-0384-1) > 89 mL in 1 BOTTLE	1 bottle	2012-08-27	0000-00-00	No	No	Current
11822-0384-2	11822038402	1 BOTTLE in 1 CARTON (11822-0384-2) > 148 mL in 1 BOTTLE	1 bottle	2013-07-18	0000-00-00	No	No	Current