Mucus Relief ER DM

Product NDC
30142-991
11-digit product format
301420991
Labeler code
30142
Product ID
30142-991_f3f6ac23-76c2-4f25-b13a-8b1915e092f2
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
KROGER COMPANY
Application
NDA021620
Marketing category
NDA
Marketing start
2019-05-30
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
600 mg/1; mg/1
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct30142-991IInactivated by FDA2026-08-17
excluded packagepackage30142-99130142-991-20IInactivated by FDA2026-08-17
excluded packagepackage30142-99130142-991-40IInactivated by FDA2026-08-17

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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage30142-991-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage30142-991-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage30142-991-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage30142-991-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage30142-991-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage30142-991-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage30142-991-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage30142-991-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage30142-991-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage30142-991-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage30142-991-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage30142-991-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage30142-991-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage30142-991-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage30142-991-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage30142-991-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage30142-991-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage30142-991-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage30142-991-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage30142-991-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage30142-991-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage30142-991-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage30142-991-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage30142-991-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage30142-991-408af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage30142-991-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage30142-991-40834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage30142-991-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage30142-991-401332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage30142-991-201332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage30142-991-20fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage30142-991-40fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage30142-991-2086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage30142-991-4086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage30142-991-20bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage30142-991-40bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021620-001MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29
N021620-002MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29bb7c543d1eb4…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021620-00163722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00169558212020-04-28U-685Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00178380322020-04-28Drug product2010-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00263722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00269558212020-04-28U-685Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00278380322020-04-28Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021620-00163722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00169558212020-04-28U-685Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00178380322020-04-28Drug product2010-12-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00263722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00269558212020-04-28U-685Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00278380322020-04-28Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021620-00163722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00169558212020-04-28U-685Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00178380322020-04-28Drug product2010-12-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00263722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00269558212020-04-28U-685Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00278380322020-04-28Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021620-00163722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00169558212020-04-28U-685Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00178380322020-04-28Drug product2010-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00263722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00269558212020-04-28U-685Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00278380322020-04-28Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021620-00163722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00169558212020-04-28U-685Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00178380322020-04-28Drug product2010-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00263722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00269558212020-04-28U-685Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00278380322020-04-28Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021620-00163722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00169558212020-04-28U-685Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00178380322020-04-28Drug product2010-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00263722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00269558212020-04-28U-685Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00278380322020-04-28Drug productea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-991-202022-01-28C16284748780-1d6a99b39-d3dd-a426-e053-dadaa90af4c2Mucus Relief ER DM Extended Release
30142-991-402022-01-28C16284748780-1d6a99b39-d3dd-a426-e053-dadaa90af4c2Mucus Relief ER DM Extended Release

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-991-20Mucus Relief ER DM Extended Release20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE203
30142-991-20Mucus Relief ER DM Extended Release1 in 1 CARTONTABLET, EXTENDED RELEASE13
30142-991-40Mucus Relief ER DM Extended Release2 in 1 CARTONTABLET, EXTENDED RELEASE23
30142-991-40Mucus Relief ER DM Extended Release40 in 1 BLISTER PACKTABLET, EXTENDED RELEASE403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-991MUCUS RELIEF ER DM EXTENDED RELEASE (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [KROGER COMPANY]3Legacy NDC, 4 package rows20200212_33baf963-b29c-4d89-8423-7d91000acae8.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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC70987d06-d206-445f-bd0d-5e1345b8465c2026-06-15WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC588eddc1-fa30-41cc-8ed9-c01319ea21c62026-05-27WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsc04e67da-51f6-4ce3-9852-419d7b3a37422026-05-22WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESportpharm LLC8f4af6dd-6df4-49a7-98cf-6551369237342026-02-26WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESelect Consumer Group3c9c8fb0-8a00-4b0f-e063-6394a90af6322025-12-28WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
MUCINEX DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsfcaf1df9-b396-44f2-94ce-e46e80aba66c2025-10-01WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DM, TRAVEL BASIXGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.c274b05c-8f05-4980-9a93-77affb322e572023-10-10WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions104b29ed-a377-4436-8e24-413c63579f2e2023-07-27WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINNavajo Manufacturing Company Inc.4226f394-f85e-45b1-8d5f-7cffb7dd492f2023-03-16WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN33baf963-b29c-4d89-8423-7d91000acae83
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD33baf963-b29c-4d89-8423-7d91000acae83
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY33baf963-b29c-4d89-8423-7d91000acae83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-991-20301420991201 BLISTER PACK in 1 CARTON (30142-991-20) > 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2019-05-300000-00-00NoNoCurrent
30142-991-40301420991402 BLISTER PACK in 1 CARTON (30142-991-40) > 40 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2019-05-300000-00-00NoNoCurrent