Robitussin
- Product NDC
- 0031-2103
- 11-digit product format
- 000312103
- Labeler code
- 0031
- Product ID
- 0031-2103_430487ce-fbd6-66fc-e063-6294a90a32bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan hydrobromide, guaifenesin, doxylamine succinate
- Dosage form
- KIT
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-03-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Brand name suffix
- Day and Night Maximum Strength Cough DM
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 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 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0031-2103-01 | RobitussinDay and Night Maximum Strength Cough DM | 1 in 1 CARTON | KIT | 1 | 1 | |
| 0031-8718-13 | RobitussinDay and Night Maximum Strength Cough DM | 1 in 1 CARTON | SOLUTION | 12.5 mg in 20mL | 1 | |
| 0031-8718-13 | RobitussinDay and Night Maximum Strength Cough DM | 118 mL in 1 BOTTLE | SOLUTION | 118 mL | 30 mg in 20mL | 1 |
| 0031-8739-12 | RobitussinDay and Night Maximum Strength Cough DM | 118 mL in 1 BOTTLE | SOLUTION | 118 mL | 20 mg in 20mL | 1 |
| 0031-8739-12 | RobitussinDay and Night Maximum Strength Cough DM | 1 in 1 CARTON | SOLUTION | 400 mg in 20mL | 1 |
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 |
|---|---|---|---|---|---|---|
| Walgreens NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | WALGREEN COMPANY | 5bf72e2f-15c8-466a-9e13-50654233da91 | 2026-01-19 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | 9862f84d-1c18-4ef7-86dc-98572599d417 | 2026-01-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 37853689-c9ca-4bc7-9c5b-4a68b8d778be | 2026-01-19 | Warnings | M012 |
| VAPORX | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | AKRON PHARMA INC | 51b32162-0c5a-4b5b-999a-34337d816603 | 2026-01-19 | Warnings | M012 |
| Equate | OXYMETAZOLINE HCL | Walmart Inc | 2f762c24-2442-506a-e063-6394a90a3b96 | 2026-01-19 | Warnings | M012 |
| Dimetane | DIPHENHYDRAMINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 2026-01-19 | Warnings | M012 |
| nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | f681d986-9838-42d8-8ed9-732a39fbf870 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | H E B | 22d241c5-a3fd-4619-8147-91d7a4c8cf98 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | Better Living Brands, LLC | 9fe63ca6-3863-4175-9aec-ecd6ebbdb249 | 2026-01-19 | Warnings | M012 |
| Good Neighbor Pharmacy Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | 5749ce9d-e182-478f-ab88-b520a35a99a7 | 2026-01-19 | Warnings | M012 |
| Foster and Thrive Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Strategic Sourcing Services LLC | 1d9150b1-2f6c-4c33-8c93-3ed1d88585e2 | 2026-01-18 | Warnings | M012 |
| HealthWise Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | ce3ceffd-3ff5-3795-e053-2995a90a827f | 2026-01-18 | Warnings | M012 |
| topcare nite time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Topco Associates LLC | 31210a95-f9dc-49db-aab5-25c4dca49266 | 2026-01-17 | Warnings | M012 |
| Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f77226c0-b6d5-9fd0-e053-6294a90a4b57 | 2026-01-16 | Warnings | M012 |
| Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f691734b-5cf4-6eb8-e053-2a95a90aee80 | 2026-01-16 | Warnings | M012 |
| Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f771aa19-295a-9f4e-e053-6294a90a1674 | 2026-01-16 | Warnings | M012 |
| CVS Cherry Cough Drops | MENTHOL | CVS Pharmacy | de5c4b94-0420-5d43-e053-2995a90aa5a5 | 2026-01-16 | Warnings | M012 |
| CVS Honey Lemon Cough Drops | MENTHOL | CVS Pharmacy | de963dc3-8108-440f-e053-2995a90a906f | 2026-01-16 | Warnings | M012 |
| CVS SF Menthol Cough Drops | MENTHOL | CVS Pharmacy | e08f8ca3-b683-4964-e053-2a95a90afabb | 2026-01-16 | Warnings | M012 |
| CVS SF Honey Lemon Cough Drops | MENTHOL | CVS Pharmacy | e0cdeccf-c32f-318a-e053-2a95a90ac401 | 2026-01-16 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2056073 | {1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } Pack | GPCK | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 2056073 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) Pack | PSN | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1115329 | dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution | PSN | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1115329 | dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution | SCD | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 2056073 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) Pack | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1115329 | dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1115329 | dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0031-2103-01 | 00031210301 | 1 KIT in 1 CARTON (0031-2103-01) * 1 BOTTLE in 1 CARTON (0031-8739-12) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0031-8718-13) / 118 mL in 1 BOTTLE | 1 kit | 2021-03-01 | No | No | Current |
| 0031-8718-13 | 00031871813 | 1 in 1 CARTON | Historical | ||||
| 0031-8739-12 | 00031873912 | 118 mL in 1 BOTTLE | 118 ml | Historical |