Caring Mill Childrens Cough DM

Product NDC: 81522-958
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	81522-958		D	Discontinued by firm		2026-10-05
excluded package	package	81522-958	81522-958-28	D	Discontinued by firm		2026-10-05

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…`

Reported adverse events (FAERS/openFDA)#

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

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 2 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough DM	DEXTROMETHORPHAN POLISTIREX	H E B	f8f225cd-a0f2-4991-828f-cc7549778235	2025-11-01	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Topcare Cough DM	DEXTROMETHORPHAN POLISTIREX	Topco Associates LLC	d1740816-425d-4327-9cff-6ca5ce430d0c	2025-10-31	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Leader Cough DM	DEXTROMETHORPHAN POLISTIREX	Cardinal Health 110, LLC. dba Leader	4c99b5e3-cd79-4c54-ae37-3673c836e668	2025-10-31	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Publix Super Markets Inc	5a71cad4-8816-47f4-840c-27765d377f0a	2025-09-26	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Meijer Distribution Inc	fb6fce1e-2dea-485c-be18-c6764454fe25	2025-09-26	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm childrens	DEXTROMETHORPHAN POLISTIREX	Meijer Distribution Inc	8af9367e-aa0b-4f9e-a7df-737d5411bc3c	2025-06-13	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	ATLANTIC BIOLOGICALS CORP.	73aede9d-37dd-4aa5-a906-0e0c94cecff1	2025-05-12	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Meijer Distribution Inc	3febf0e0-b587-495a-9608-3a2dfbc32791	2025-05-07	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
dextromethorphan polistirex extended release	DEXTROMETHORPHAN POLISTIREX	Bryant Ranch Prepack	bd415342-90e1-411b-b6c9-652e9532c611	2025-04-02	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
dextromethorphan polistirex extended release	DEXTROMETHORPHAN POLISTIREX	Padagis Israel Pharmaceuticals Ltd	7a6b68eb-8fe0-447d-aed7-28432c45b58c	2025-02-11	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	CVS Pharmacy	a9765a9b-3ae3-45bc-ab59-06ec5249e2c9	2025-02-11	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Robitussin 12 Hour Cough Relief	DEXTROMETHORPHAN POLISTIREX	Haleon US Holdings LLC	5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5	2024-04-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Childrens Robitussin 12 Hour Cough Relief	DEXTROMETHORPHAN POLISTIREX	Haleon US Holdings LLC	6bcad434-5714-443c-ba83-ed534df9f20a	2024-04-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
equaline cough dm	DEXTROMETHORPHAN POLISTIREX	United Natural Foods, Inc. dba UNFI	16de32bb-1d02-470b-82b6-9b4366e19817	2023-07-24	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
signature care 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Safeway	6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a8	2023-06-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Walgreen Company	be67fb34-6ecb-4b45-9a67-3f78f4af8e36	2023-06-06	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Walgreen Company	c628923a-6771-4aba-9e2d-4795c9effb33	2023-04-04	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	CVS Pharmacy	cb71164f-e4bf-48b9-a8b1-f7271d38a588	2022-06-29	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
signature care childrens 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Safeway	62d71572-d157-484a-8676-7ce6da413ee8	2022-06-01	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
basic care cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	8127c389-c1e3-4f2e-b306-13587b5b50c4	2021-08-09	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

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