Rompe Tos X Children
- Product NDC
- 69729-784
- Requested package NDC
- 69729-784-06
- 11-digit product format
- 697290784
- Labeler code
- 69729
- Product ID
- 69729-784_30b942ce-4452-9123-e063-6394a90ae60f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-18
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 250; 5; 13.33; 200 mg/10mL; mg/10mL; mg/10mL; mg/10mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- Rompe Tos X Children
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/10mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 13.33 mg/10mL |
| GUAIFENESIN | 200 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1790651 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 05cc932d-b412-0710-e063-6394a90a87f6 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69729-784-06 | 2025-12-23 | C162847 | 48780-1 | 2cef2736-61b6-d83d-e063-dadaa90ab31f | Rompe Tos X Children |
| 69729-784-06 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-61b6-d83d-e063-dadaa90ab31f | Rompe Tos X Children |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-784-06 | Rompe Tos X Children | 1 in 1 CARTON | SYRUP | 1 | 3 | |
| 69729-784-06 | Rompe Tos X Children | 177 mL in 1 BOTTLE, PLASTIC | SYRUP | 177 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Childrens Sudafed Nasal Decongestant | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 52e9307b-ad38-4f65-bb2f-4fa262e82010 | 2024-11-08 | Warnings | M012 |
| Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 685b51d3-cc25-47b2-ac8a-368924f43137 | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 60183922-bfd3-4377-884a-51b2f0a4c93a | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Congestion | PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 2ca08917-1a75-4365-8520-c083e6a4225a | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Head Congestion Plus Mucus | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | f0739186-41b9-4761-adf7-08101b30a18e | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Head Congestion Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 1e528f78-0ced-4a06-935a-84056c921727 | 2024-11-08 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 657a1e59-104c-4152-b2c9-00a8b82dc78e | 2024-11-08 | Warnings | M012 |
| Tylenol Cold plus Flu Severe and Tylenol Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 47c61858-72ce-409b-a3af-a63620cf7d13 | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | b8b75904-3806-4258-89c1-d6ff486ed41c | 2024-11-08 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 464de5de-0e7a-41d6-875f-dd0e5fe7893c | 2024-11-08 | Warnings | M012 |
| McKesson Phenylephrine HCl | PHENYLEPHRINE HCL | McKesson Medical-Surgical | e09060f7-ca0b-5f7c-e053-2995a90ab344 | 2024-11-08 | Warnings | M012 |
| daytime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | e0e216ef-300c-4f57-87e6-62a5327e09b4 | 2024-11-08 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 969c0718-ba6e-4edb-9f55-43bc9500450f | 2024-11-08 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | 62a70d9a-4e78-497c-8f75-012ab94e92f6 | 2024-11-08 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Publix Super Markets Inc | 25b2ad8a-5835-4496-815f-73a7fb40dcfd | 2024-11-08 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 296f20c0-8b5f-4a08-9329-f93c92e63867 | 2024-11-08 | Warnings | M012 |
| topcare tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Topco Associates LLC | d3cae69e-41a5-4099-a3f4-ce25fd94df73 | 2024-11-08 | Warnings | M012 |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 9d147d1e-8ea5-4e0f-8ae8-1da16f119496 | 2024-11-08 | Warnings | M012 |
| equate adult cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | WALMART INC. | e770bdb2-3662-4538-8199-fe4a4059c720 | 2024-11-08 | Warnings | M012 |
| DG Health Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | 23dcb627-c867-435f-9d1a-a9f49e58b58f | 2024-11-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1790651 | acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution | PSN | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
| 1790651 | acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
| 1790651 | acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
| 1790651 | acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
| 1790651 | APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 69729-784-06 | 69729078406 | 1 BOTTLE, PLASTIC in 1 CARTON (69729-784-06) / 177 mL in 1 BOTTLE, PLASTIC | 2023-09-18 | No | No | Current |