Vicks Sinex D
- Product NDC
- 37000-921
- Requested package NDC
- 37000-921-30
- 11-digit product format
- 370000921
- Labeler code
- 37000
- Product ID
- 37000-921_a60103b7-a911-8a3d-e053-2a95a90a8831
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- ANDA076518
- Marketing category
- ANDA
- Marketing start
- 2018-12-17
- Marketing end
- 2021-03-01
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE; NAPROXEN SODIUM
- Active strength
- 120 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
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 | 37000-921 | 37000-921-30 | D | Discontinued by firm | 2026-08-11 |
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… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG BASE;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG BASE;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | cb3db0bc1861… |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 37000-921 | VICKS SINEX D SEVERE SINUS AND COLD (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 2 | Legacy NDC | 20200520_7d3ee6a9-e482-af6a-e053-2a91aa0a64d6.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 DS 12HR COLD, FEVER and SINUS | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 4e7e6674-c1ce-ea61-e063-6294a90afe04 | 2026-05-12 | Warnings | 076518 ANDA076518 |
| Aleve-D Sinus and Headache | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5ab980c0-c48a-233b-e053-2991aa0a4fd1 | 2025-12-04 | Warnings | 076518 ANDA076518 |
| Aleve-D Sinus and Cold | NAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 599ea6c8-03ad-536e-e053-2991aa0a83a3 | 2025-12-04 | Warnings | 076518 ANDA076518 |
| Leader All Day Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Cardinal Health 110, LLC. dba Leader | 83f7cfbb-ab84-4594-ae7a-4a657385c8a7 | 2025-04-25 | Warnings | 076518 ANDA076518 |
| All Day Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Walgreen Company | b0417ce5-3a5e-42cb-8672-9f2b133c91ca | 2025-04-25 | Warnings | 076518 ANDA076518 |
| Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Meijer Distribution Inc | cb78330b-d8a3-4c16-bbb0-d31368a542e6 | 2025-04-18 | Warnings | 076518 ANDA076518 |
| Topcare Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Topco Associates LLC | 55c177ce-1729-4a9b-a5ae-2b6c96fbc27a | 2025-04-17 | Warnings | 076518 ANDA076518 |
| Sudafed Sinus 12 Hour Pressure plus Pain | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 305adca3-cdae-41e5-a10a-99d9dd0fe390 | 2024-11-08 | Warnings | 076518 ANDA076518 |
| Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 9e142ac7-c8b1-449b-a224-c7db0fc0e4cf | 2024-07-10 | Warnings | 076518 ANDA076518 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-921-30 | 37000092130 | 3 BLISTER PACK in 1 CARTON (37000-921-30) > 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2018-12-17 | 2021-03-01 | No | No | Current |