Robitussin Maximum Strength Cough Plus Chest Congestion DM
- Product NDC
- 0031-8719
- 11-digit product format
- 000318719
- Labeler code
- 0031
- Product ID
- 0031-8719_cb5018d5-8b32-41b8-a393-008d092d4638
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan hydrobromide and guaifenesin
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-05-23
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10; 200 mg/1; mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- 2027-12-31
- Current FDA listing
- Yes
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0031-8719 | 0031-8719-31 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 0031-8719 | 0031-8719-70 | D | Discontinued by firm | 2026-10-16 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0031-8719-31 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0031-8719-70 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 0031-8719-00 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 0031-8719-00 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 0031-8719-00 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 0031-8719-00 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 5b2001dcd8f5… | 54b53d4dc9e4… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Robitussin Maximum Strength Cough Plus Chest Congestion DM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1111663 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 868ac65a-63e2-46ac-b87d-66b289086756 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0031-8719-10 | Robitussin Maximum Strength Cough Plus Chest Congestion DM | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 11 | |
| 0031-8719-10 | Robitussin Maximum Strength Cough Plus Chest Congestion DM | 5 in 1 CARTON | CAPSULE, LIQUID FILLED | 5 | 11 | |
| 0031-8719-20 | Robitussin Maximum Strength Cough Plus Chest Congestion DM | 10 in 1 CARTON | CAPSULE, LIQUID FILLED | 10 | 11 | |
| 0031-8719-20 | Robitussin Maximum Strength Cough Plus Chest Congestion DM | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 11 | |
| 0031-8719-31 | Robitussin Maximum Strength Cough Plus Chest Congestion DM | 15 in 1 CARTON | CAPSULE, LIQUID FILLED | 15 | 11 | |
| 0031-8719-31 | Robitussin Maximum Strength Cough Plus Chest Congestion DM | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 11 | |
| 0031-8719-70 | Robitussin Maximum Strength Cough Plus Chest Congestion DM | 500 in 1 BOX | CAPSULE, LIQUID FILLED | 500 | 11 | |
| 0031-8719-70 | Robitussin Maximum Strength Cough Plus Chest Congestion DM | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0031-8719-10 | EA - Each | 0031-8719 | cdff10de-74af-49f2-af0a-7b4495f38d2a | 1 | 2025-01-14 |
| 0031-8719-20 | EA - Each | 0031-8719 | 1c77274b-0f1f-4b55-b9b3-18f4167f56a3 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0031-8719 | ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC] | 10 | Current NDC, Legacy NDC, 8 package rows | 20240316_868ac65a-63e2-46ac-b87d-66b289086756.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tukol Max Action Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | cf0987a3-2c1d-4f40-8551-df9a8e08cd3d | 2026-08-03 | Warnings | M012 |
| Pressure, Pain and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 7d42e164-86e9-4baa-a389-3271cf99920e | 2026-08-03 | Warnings | M012 |
| DG Health Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp Inc | ed754d5c-74e1-4dee-a5c5-10ccec1b81db | 2026-08-03 | Warnings | M012 |
| RIGHT REMEDIES Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Strive Pharmaceuticals Inc. | 51c4dcfb-8725-d547-e063-6394a90ac04c | 2026-07-31 | Warnings | M012 |
| Stona for Children | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Sato Pharmaceutical Co., Ltd. | 18f3d694-9dff-407e-a264-916dbd201f9a | 2026-07-31 | Warnings | M012 |
| Stonarhini | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE | Sato Pharmaceutical Co., Ltd. | cc353280-0b4c-418c-93fe-850125955009 | 2026-07-31 | Warnings | M012 |
| cold and flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Meijer Distribution Inc | 5519e918-71cb-4430-ae57-e03cd5ac6002 | 2026-07-31 | Warnings | M012 |
| Good Neighbor Pharmacy allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Amerisource Bergen | 9819522f-f3db-4cb8-9680-423114ace2f6 | 2026-07-31 | Warnings | M012 |
| Sinus Relief Daytime, Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 352b89b5-6995-4873-a103-e8f89074fdc9 | 2026-07-30 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | ce590997-3cae-4f22-ac39-2b14d39494bc | 2026-07-30 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer Distribution Inc | f1e83e43-011c-4470-bd55-fb2818a9fc84 | 2026-07-30 | Warnings | M012 |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a302e341-1c00-4c3d-b71f-c4c0b307aa67 | 2026-07-29 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 4c737cd6-fe56-4cef-887c-cd6cf83b254c | 2026-07-29 | Warnings | M012 |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | M012 |
| TOPCARE NITE TIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d | 2026-07-29 | Warnings | M012 |
| DAYTIME COLD AND FLU NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer Distribution Inc | 3a33c6ce-aada-4099-8c61-49c86c0fc1a8 | 2026-07-29 | Warnings | M012 |
| Tussin DM Max Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 668c92ce-6c1f-4ab3-b0dd-822b0768cb5e | 2026-07-29 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 702f9786-7ce9-43e4-921d-e1db09612127 | 2026-07-28 | Warnings | M012 |
| LoHist-D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | efaa354e-c25c-405b-9d30-001c2796978c | 2026-07-28 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111663 | dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral Capsule | PSN | 868ac65a-63e2-46ac-b87d-66b289086756 | 11 |
| 1111663 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral Capsule | SCD | 868ac65a-63e2-46ac-b87d-66b289086756 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0031-8719-10 | 00031871910 | 5 BLISTER PACK in 1 CARTON (0031-8719-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 5 blister pack | 2016-05-02 | 0000-00-00 | No | No | Current |
| 0031-8719-20 | 00031871920 | 10 BLISTER PACK in 1 CARTON (0031-8719-20) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 10 blister pack | 2013-05-23 | 0000-00-00 | No | No | Current |
| 0031-8719-31 | 00031871931 | 15 in 1 CARTON | Historical | |||||
| 0031-8719-70 | 00031871970 | 500 in 1 BOX | Historical |