NDC 35916-0189-01 - Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 35916-0189
- Requested NDC
- 35916-0189-01
- Package NDCs from labels
- 35916-0189-1, 35916-0189-01
- Manufacturer
- SOFTGEL HEALTHCARE PRIVATE LIMITED
- Effective date
- 2026-01-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| FD&C BLUE NO. 1 - SOFTGEL HEALTHCARE PRIVATE LIMITED | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2026-01-27 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0189-1 | Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 35916-0189 | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PRIVATE LIMITED] | 1 | Current NDC, 1 package rows | 20250409_2f7f078e-de04-9d53-e063-6394a90a409f.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 |
|---|---|---|---|---|---|---|
| Mucinex Sinus-Max Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 128f3442-9802-4303-80be-aead09237936 | 2026-05-13 | Warnings | M012 362O9ITL9D |
| Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 33f0d9bb-c67d-92ba-e063-6294a90a9943 | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain, Maximum Strength | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2c01962d-74e3-4dfa-b7cb-a91a687711d5 | 2026-05-13 | Warnings | M012 362O9ITL9D |
| Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | f5365c6d-9296-41a5-953a-d1008954e67f | 2026-05-13 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8905706b-b9da-4520-8cf2-87d7c125edf3 | 2026-05-13 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| MUCINEX Rapid Clear Day Night and Clear and Cool Nasal | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 37dcb0ed-df56-1bec-e063-6394a90a695e | 2026-05-13 | Warnings | M012 |
| Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 373e0d75-8def-4b98-e063-6394a90a5e47 | 2026-05-13 | Warnings | M012 |
| MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5a397466-8721-4060-a178-5ebfd7069cc9 | 2026-05-13 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | 350764de-7801-b24e-e063-6394a90ab3c3 | 2026-05-13 | Warnings | M012 362O9ITL9D |
| Cepacol Extra Strength Sore Throat and Cough | BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | c0cc32db-90f0-4106-8538-89821083ece1 | 2026-05-13 | Warnings | M012 9D2RTI9KYH |
| Mucinex Nightshift Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | d9467ca2-df75-4fa1-92b3-d2101eb54a77 | 2026-05-13 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Mucinex Nightshift Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 12420092-3ef6-464b-9106-2d56cd6ef200 | 2026-05-13 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Mucinex Nightshift Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 09fdf96f-345f-43f2-9f0f-8303ac70849e | 2026-05-13 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| blink tears | POLYETHYLENE GLYCOL 400 | Bausch & Lomb Incorporated | f1d07347-086f-43b2-aa5f-910764fc666e | 2026-05-13 | Warnings | B697894SGQ |
| Mucinex Childrens Mighty Chews Night Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 2ce31244-9c6c-b7dd-e063-6394a90a31a8 | 2026-05-13 | Warnings | M012 9D2RTI9KYH V9BI9B5YI2 362O9ITL9D |
| Sleep Aid | DOXYLAMINE SUCCINATE | Strategic Sourcing Services LLC | eddec8bc-2bed-4bc5-a1c2-39424a699838 | 2026-05-13 | Warnings | V9BI9B5YI2 |
| Acetaminophen | ACETAMINOPHEN | Acetris Pharma Holdings, LLC | dacbe2eb-f412-4629-a8ff-237c7fd10ab6 | 2026-05-13 | Warnings | 362O9ITL9D |
| Sleep Aid | DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 71e0cef1-6195-4b67-9c1f-b4e5fbeae53c | 2026-05-13 | Warnings | V9BI9B5YI2 |
| equate daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 2ac53cc7-000f-41fd-b799-4e6d6886fe62 | 2026-05-13 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | 2201d5c0-bd51-47a7-9775-916b18573623 | 2026-05-13 | Warnings | M012 9D2RTI9KYH V9BI9B5YI2 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.