Good Sense Severe NightTime Cold and Flu
- Product NDC
- 0113-0763
- 11-digit product format
- 001130763
- Labeler code
- 0113
- Product ID
- 0113-0763_1ee69047-5341-4c54-8e2b-8f3002ff6aa1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- L. Perrigo Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-11-19
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 0113-0763 | 0113-0763-34 | D | Discontinued by firm | 2026-10-21 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
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
- Good Sense Severe NightTime Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1431245 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0113-0763-34 | Good Sense Severe NightTime Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | 10 | |
| 0113-0763-40 | Good Sense Severe NightTime Cold and Flu | 354 mL in 1 BOTTLE | SOLUTION | 354 | 10 | |
| 0113-0763-40 | GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME | 354 mL in 1 BOTTLE | SOLUTION | 354 mL | 650 mg in 30mL | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-0763-34 | ML - Milliliter | 0113-0763 | b4b821da-421e-48e2-ae9a-4d6de73d82e6 | 1 | 2024-03-12 |
| 0113-0763-40 | ML - Milliliter | 0113-0763 | 00575054-a923-441f-b070-45b80e64ce07 | 1 | 2022-03-09 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0113-0763 | GOOD SENSE SEVERE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [L. PERRIGO COMPANY] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241101_f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2.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 |
|---|---|---|---|---|---|---|
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2025-08-01 | Warnings | M012 |
| meijer Nighttime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 377248b6-d64d-8dff-e063-6394a90a43f6 | 2025-07-31 | Warnings | M012 |
| meijer Daytime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 3771f778-7ac9-7108-e063-6394a90a1105 | 2025-07-31 | Warnings | M012 |
| tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca | 2025-07-31 | Warnings | M012 |
| Equate Nasal | OXYMETAZOLINE HCL | Wal-Mart Stores Inc | c38a2783-aed9-466d-8976-59d03a792c04 | 2025-07-30 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3b15d2ea-f784-275d-e063-6394a90a800c | 2025-07-29 | Warnings | M012 |
| Respiratory Relief | GUAIFENESIN | Schwabe North America, Inc | f683041a-4ff9-42a5-9047-a9a3140a8758 | 2025-07-29 | Warnings | M012 |
| Childrens Robitussin Honey Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | b87f700e-3414-463c-80d4-c3dbca89a488 | 2025-07-29 | Warnings | M012 |
| Tussin DM | TUSSIN DM | Allegiant Health | 7a2f8d48-3123-4c37-b238-bd7cc4242bb7 | 2025-07-23 | Warnings | M012 |
| Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GADAL Laboratories, Inc | 5fb2438b-8f2d-4af2-9981-42d278d26800 | 2025-07-23 | Warnings | M012 |
| DR. SANA COUGH AND CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GADAL Laboratories, Inc | baca0580-4c30-4b94-89fa-a7cf06d4ff25 | 2025-07-22 | Warnings | M012 |
| Defensol D | ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI | Menper Distributors, Inc. | f466c660-69eb-4581-81ff-1499fa421d8b | 2025-07-22 | Warnings | M012 |
| Defensol D Blister Pack | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCI | Menper Distributors, Inc. | 0dfcc977-6101-4536-e063-6294a90a7a48 | 2025-07-22 | Warnings | M012 |
| Broncofin | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Menper Distributors, Inc. | fdf67382-1692-485b-92f1-2cbb8be4fb70 | 2025-07-22 | Warnings | M012 |
| Defensol Adult Syrup | GUAIFENESIN, DEXTROMETHORPHAN HBR | Menper Distributors, Inc. | 62acff69-8c40-4a0e-8d56-be2cc14e3d45 | 2025-07-22 | Warnings | M012 |
| Cosedal Drops | DEXTROMETHORPHAN HBR, GUAIFENESIN | Menper Distributors, Inc. | 1241d249-ea3b-4d2b-87ed-835d6a2d286a | 2025-07-22 | Warnings | M012 |
| Berro y Cebolla DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Menper Distributors, Inc. | 20107bd9-6d84-4ab5-a0d9-966f1f11d919 | 2025-07-22 | Warnings | M012 |
| Defensol-ito | DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE | Menper Distributors, Inc | a7c7a60d-d49f-4239-92f7-714eac7eb0c5 | 2025-07-22 | Warnings | M012 |
| Bisolvine Children | GUAIFENESIN, DEXTROMETHORPHAN | MENPER DISTRIBUTORS INC. | 896a5443-e3d2-4af7-9e27-f1c1899ce038 | 2025-07-22 | Warnings | M012 |
| Bisolvine Aloe-Miel | DEXTROMETHORPHAN, GUAIFENESIN | MENPER DISTRIBUTORS INC. | 34801c79-ce88-492f-808e-b639e8601607 | 2025-07-22 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 10 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 10 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 10 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 10 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 10 |
| 2637731 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | e42f9e0d-f990-4c33-af43-75acf5d77638 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0113-0763-34 | 00113076334 | 237 mL in 1 BOTTLE (0113-0763-34) | 237 ml | 2013-11-19 | 0000-00-00 | No | No | Current |
| 0113-0763-40 | 00113076340 | 354 mL in 1 BOTTLE (0113-0763-40) | 354 ml | 2013-11-19 | 0000-00-00 | No | No | Current |