Caring Mill Childrens Cough DM

Product NDC: 81522-958
Requested package NDC: 81522-958-28
11-digit product format: 815220958
Labeler code: 81522
Product ID: 81522-958_a5f7d6ba-0c8b-4c09-8d38-68b85ba4a511
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan polistirex
Dosage form: SUSPENSION
Route: ORAL
Labeler: FSA Store Inc.
Application: ANDA091135
Marketing category: ANDA
Marketing start: 2021-12-13
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 30 mg/5mL
Pharmacologic classes: Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	81522-958	81522-958-28	D	Discontinued by firm		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`f41ea6bd6efb…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81522-958	CARING MILL CHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [FSA STORE INC.]	2	Legacy NDC	20220622_4a67d436-e259-4603-a0db-a5d0a207387c.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 1 of 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Cough DM	DEXTROMETHORPHAN POLISTIREX	L. Perrigo Company	5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea	2026-08-27	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	10f51748-17b1-459d-8cc6-acc4577290aa	2026-08-20	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	43a90c58-8a7b-47cb-91ed-4afa3ec5dfb3	2026-08-13	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
12 hr relief cough dm	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	03c44e2f-d6e3-4c78-9c9a-92d1708a62fe	2026-07-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Equate Cough DM	DEXTROMETHORPHAN POLISTIREX	Wal-Mart Stores Inc	956fcc21-9e0f-41e3-9304-f379364a7d1c	2026-06-26	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
leader childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Cardinal Health 110, LLC. dba Leader	3a468feb-da54-4a2c-bfce-bfe99f77efc3	2026-06-25	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
CHILDRENS 12 HR COUGH RELIEF	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	380d7f6d-cdfe-4a22-a6e0-13fe2ae12e6c	2026-06-17	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
12 HR RELIEF COUGH DM	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d63fff6c-a1cd-4636-b1d3-ae83be40c3f7	2026-06-03	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
up and up 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Target Corporation	a8acec73-dc66-444e-9438-370893cd5129	2026-05-11	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
COUGH DM	DEXTROMETHORPHAN POLISTIREX	Safeway	58dab2f1-27b5-4522-bdc6-b710f20802eb	2026-05-04	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	Major Pharmaceuticals	cdb5616e-0f04-4b9e-a82b-994e9ba3b515	2026-04-13	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Leader Cough DM	DEXTROMETHORPHAN POLISTIREX	Cardinal Health 110, LLC. dba Leader	a07b70d0-3842-4ea6-abb4-95b4638d5e55	2026-04-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	HyVee Inc	ce7dafc6-1c23-40d2-94d0-2568298fd7ff	2026-03-06	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	HyVee Inc	20c10d74-0435-4e8a-acd7-5af1f8382c28	2026-01-27	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
DG Health Cough DM	DEXTROMETHORPHAN POLISTIREX	Dolgencorp Inc	648ca6b2-d31f-4941-baad-0f2accd30a9e	2026-01-21	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Meijer Distribution Inc	6bdfa599-7898-4c05-927c-52fb82e0e686	2026-01-02	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
TopCare Cough DM	DEXTROMETHORPHAN POLISTIREX	Topco Associates LLC	490f695c-e60f-43db-b3f3-a9ffbb2906dd	2025-12-10	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
foster and thrive 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Strategic Sourcing Services LLC	db2e79f7-827f-45da-85ba-f3a774251070	2025-12-09	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Walgreen Company	317ab8e0-c329-4d4e-9fd0-4bff4e1504cd	2025-11-20	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
foster and thrive 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Strategic Sourcing Services LLC	043072e5-b92d-4fed-bfd8-aea07956806b	2025-11-14	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81522-958-28	81522095828	1 BOTTLE in 1 CARTON (81522-958-28) > 148 mL in 1 BOTTLE	1 bottle	2021-12-13	0000-00-00	No	No	Current