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 |
|---|---|---|---|---|---|---|
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | 09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b | 2026-02-17 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | e8a48a00-3533-4c4d-94e1-8a6c6b35a792 | 2026-02-17 | Warnings | M012 |
| cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | HyVee Inc | 1f3efcdd-4976-4aef-a7c6-a5f88d13cb78 | 2026-02-17 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | HyVee Inc | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 2026-02-17 | Warnings | M012 |
| Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Chain Drug Marketing Association, Inc. | 3c8f34ad-589a-4872-939c-44ad5e0e47fe | 2026-02-17 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Valu Merchandisers Company | b6144732-99da-4be2-88e0-75f31b323d38 | 2026-02-16 | Warnings, Adverse reactions | M012 |
| topcare day time cold and flu relief multi symptom relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Topco Associates LLC | 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 2026-02-16 | Warnings | M012 |
| Revasol Acetaminophen Suspension | ACETAMINOPHEN | Rnv LLC | 4ab6bb54-7c28-0c6b-e063-6394a90ac4a6 | 2026-02-13 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Topco Associates LLC | 62eed0e8-ba5f-45c2-a543-68b50bcf4b0c | 2026-02-13 | Warnings, Adverse reactions | M012 |
| Revasol Acetaminophen Suspension Dye Free | ACETAMINOPHEN | Rnv LLC | 4abc07b3-6a27-260f-e063-6394a90a28d6 | 2026-02-13 | Warnings | M012 |
| robafen dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Major Pharmaceuticals | 5e19220d-9cf3-4732-b9aa-c09db5d69ce6 | 2026-02-13 | Warnings | M012 |
| Gencare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | 686b9456-f16d-4b99-ae58-f607448bed8b | 2026-02-13 | Warnings | M012 |
| nasal | PHENYLEPHRINE HYDROCHLORIDE | Kroger Company | 1c3dc4e6-452b-4c84-b53c-426cf9ae8f03 | 2026-02-12 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | af42d3f7-661e-4322-aefe-2b7f9f1010d6 | 2026-02-12 | Warnings | M012 |
| Childrens Giltuss D | CHILDRENS GILTUSS D | Gil Pharmaceutical Corp | cfc2493b-e99e-4b55-98a9-053f95d49844 | 2026-02-12 | Warnings | M012 |
| Giltuss D | GILTUSS D | Gil Pharmaceutical Corp | 298f5457-a7df-474d-9854-68918ee3d330 | 2026-02-12 | Warnings | M012 |
| Vaporizing | CAMPHOR | Walgreen Co. | ef4f95c8-7650-4096-9369-ea8393781bee | 2026-02-12 | Warnings, Adverse reactions | M012 |
| Oxymetazoline hydrochloride | OXYMETAZOLINE HYDROCHLORIDE | Prodose, Inc. | 3dce34f0-9f6d-8151-e063-6394a90a1d38 | 2026-02-11 | Warnings | M012 |
| SIGNATURE CARE Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | SAFEWAY | 831da7b6-25c7-4601-b7f1-1800a238b016 | 2026-02-11 | Warnings | M012 |
| Allergy Plus Congestion Relief | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0d2cf481-622f-4262-b0bd-c38fe5de6721 | 2026-02-11 | 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 |