Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime
- Product NDC
- 0031-8744
- 11-digit product format
- 000318744
- Labeler code
- 0031
- Product ID
- 0031-8744_156fd078-37b4-ddce-e063-6294a90ae226
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-07-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 15; 6.25 mg/1; mg/1; mg/1
- Pharmacologic classes
- 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]
- 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 Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 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 |
|---|---|---|---|---|---|---|
| 0031-8744-10 | Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | 5 in 1 CARTON | CAPSULE, LIQUID FILLED | 5 | 5 | |
| 0031-8744-10 | Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0031-8744 | ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM 7 IN 1 RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240408_e7cf7c5d-5c9a-4201-9e30-1cd616071855.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 |
|---|---|---|---|---|---|---|
| Good Neighbor Pharmacy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Amerisource Bergen | b173cc2c-7c4c-4f9e-a920-c71bc256ec1e | 2024-07-18 | Warnings | M012 |
| ALLERGY | CHLORPHENIRAMINE MALEATE | A-S Medication Solutions | b199b5ee-fff3-4746-be68-a04060586f8e | 2024-07-18 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | H E B | 2d1715b3-b1cf-455d-9909-f6d58c97db40 | 2024-07-18 | Warnings | M012 |
| careone allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | American Sales Company | ed4038fc-ab39-4567-9961-2b390b91b126 | 2024-07-17 | Warnings | M012 |
| Topcare childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Topco Associates LLC | 6b784cde-3152-4421-a825-dd1fc601aa7a | 2024-07-17 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 4c6b6379-3a7f-4507-a792-7b69a7f3ba82 | 2024-07-17 | Warnings | M012 |
| Mucus Relief Cold Flu Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 04defcf6-e20e-402b-b725-d9394a0146b1 | 2024-07-16 | Warnings | M012 |
| basic care allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Amazon.com Services LLC | 7d237d37-21c7-476d-a8b7-d91ea1b472ee | 2024-07-16 | Warnings | M012 |
| Berkley and Jensen Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | BJWC | b52fc311-8853-4116-941b-8be35456abba | 2024-07-16 | Warnings | M012 |
| Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL | Walgreens | 0b9a4438-7d13-484c-a614-2dedc24974dc | 2024-07-16 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Publix Super Markets Inc | 23a98385-28cc-4fac-8c87-b3ced8106532 | 2024-07-16 | Warnings | M012 |
| Walgreens Moisturizing Ultra Fine Mist with Aloe | 0.05% OXYMETAZOLINE | Walgreens Company | aad01028-cbe0-4c10-adbc-d157bfa5af09 | 2024-07-16 | Warnings | M012 |
| Basic Care severe cold and cough | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 924bf427-b054-46af-b341-ff162946cd58 | 2024-07-15 | Warnings | M012 |
| Maximum Strength Cold Tabs | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | JHK DBA American Safety & First Aid | e7d4fe9a-eb09-4266-90c9-290f61ce6ad0 | 2024-07-15 | Warnings | M012 |
| ACTIDOM DA | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 7797c22e-ffeb-4798-9fb6-aa64cf077ba7 | 2024-07-15 | Warnings | M012 |
| Nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1cf3064d-4ddd-63b9-e063-6294a90aa547 | 2024-07-11 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1ccbdb53-3f70-28da-e063-6394a90a9ae0 | 2024-07-09 | Warnings | M012 |
| AXIV Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 1cd2a6f1-31ad-e507-e063-6394a90aba58 | 2024-07-09 | Warnings | M012 |
| Poly Hist Forte | DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aa0015b-8fc1-7951-e053-2a95a90a8e72 | 2024-07-09 | Warnings | M012 |
| DECONEX DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aab8e5c-1633-2e5a-e053-2a95a90adcc5 | 2024-07-09 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0031-8744-10 | 00031874410 | 5 BLISTER PACK in 1 CARTON (0031-8744-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 5 blister pack | 2018-07-01 | 0000-00-00 | No | No | Current |