Rompe Tos X Children
- Product NDC
- 69729-784
- 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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69729-784-06 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69729-784-06 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69729-784-06 | 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 |
|---|---|---|---|---|---|---|
| Foster and Thrive Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 5372f764-985e-4a42-bc97-cb0dc90fcd9c | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion and Cough Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | TOPCO ASSOCIATES LLC | 5a2d0464-038d-4c3f-b39e-ee9984fb383e | 2024-12-18 | Warnings | M012 |
| Always Save Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Valu Merch | a72b6a97-f97f-44bb-8d55-ac48b8ba45c5 | 2024-12-18 | Warnings | M012 |
| Harris Teeter Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 4ebe1d94-bb15-4250-a4c2-8cd45743c7dd | 2024-12-18 | Warnings | M012 |
| Care One Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | RETAIL BUSINESS SERVICES , LLC | f6657dee-9f32-45b1-8e44-1ad67a4a68bd | 2024-12-18 | Warnings | M012 |
| Childrens Metapp Daytime | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Guardian Drug Company | 40565500-944b-47f2-8563-5df05469e418 | 2024-12-18 | Warnings | M012 |
| CVS Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | CVS Pharmacy, Inc. | 884abed2-e355-4134-92f1-591f3a18f71d | 2024-12-18 | Warnings | M012 |
| CVS Health Chest Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | CVS Pharmacy, Inc. | a49020e8-739e-47ec-8141-e866479a3ab3 | 2024-12-18 | Warnings | M012 |
| Family Wellness Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Family Dollar Services Inc | 8aee8108-a4e0-4956-8e37-6b3b1c5dc683 | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion Relief | GUAIFENESIN | TOPCO ASSOCIATES LLC | b8339617-17ce-4ad7-af38-399ecc74d864 | 2024-12-18 | Warnings | M012 |
| Kroger Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | THE KROGER CO | 976bfdcf-2110-486c-aa6e-cd2067334cdc | 2024-12-18 | Warnings | M012 |
| Good Neighbor Pharmacy Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | AmerisourceBergen Drug Corp | 79cefd46-bd19-4a1d-9cb1-e85ff0f12494 | 2024-12-18 | Warnings | M012 |
| Leader Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Cardinal Health | 8397e1b9-e83e-4c6a-b858-1663c2365840 | 2024-12-18 | Warnings | M012 |
| GNP Mucus Relief PE | GUAIFENESIN/PHENYLEPHRINE | AmerisourceBergen Drug Corp | 63932e68-b09d-4500-bc1d-cfb2c267df1c | 2024-12-18 | Warnings | M012 |
| Meijer Chest Congestion Relief | GUAIFENESIN | Meijer Distribution Inc. | ae02e0bd-d9e7-495f-b01f-b135b96934a0 | 2024-12-18 | Warnings | M012 |
| Topcare Chest Congestion and Sinus Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | TOPCO ASSOCIATES LLC | b6c0362f-86ca-4f08-ba53-800c6df2c025 | 2024-12-18 | Warnings | M012 |
| Sunmark Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 10cad9a7-1223-470c-9027-807891217d40 | 2024-12-18 | Warnings | M012 |
| Kroger Mucus Relief | GUAIFENESIN | THE KROGER CO | 2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e | 2024-12-18 | Warnings | M012 |
| Quality Choice Mucus Relief | GUAIFENESIN | Chain Drug Marketing Association | 41f88b43-3e0a-4650-b167-a72afe6177e8 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Rugby Laboratories | 5da36516-9f94-49cb-9421-0c310abcd116 | 2024-12-18 | 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 |