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 |
|---|---|---|---|---|---|---|
| Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | DeMoulas Market Basket | e92d2f64-9690-42d3-b787-cafade3a8999 | 2023-12-29 | Warnings | M012 |
| Cold and Sinus Maxium Strength | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | 6e5ca8e1-5a03-4e77-b385-d44387fb3bfc | 2023-12-29 | Warnings | M012 |
| Cold, Flu and Sore Throat Maxium Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | d98029c0-ccd9-47e1-996f-c7786cd4ecca | 2023-12-29 | Warnings | M012 |
| MAXIMUM STRENGTH Sinus Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 0f2be061-bd0a-4e62-b994-6d0768ea647a | 2023-12-29 | Warnings | M012 |
| Tussin CF Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | c19b9997-4037-48f3-b905-86da421a292d | 2023-12-29 | Warnings | M012 |
| HempNesic | MENTHOL, CAMPHOR | Blaine Labs Inc. | 0239ada0-644d-4ef4-a3b8-df70246a3bc2 | 2023-12-21 | Warnings | M012 |
| HempNesic | MENTHOL, CAMPHOR | Blaine Labs Inc. | a698502d-c1c5-41ca-8142-74338b834c8b | 2023-12-21 | Warnings | M012 |
| Father Johns Cough Medicine Plus | NASAL DECONGESTANT | Oakhurst Company | 8b8aab0f-251b-6bd8-e053-2995a90ad748 | 2023-12-18 | Warnings | M012 |
| Father Johns Medicine | DEXTROMETHORPHAN HBR | Oakhurst Company | 8b8a249d-55af-cc98-e053-2995a90a431d | 2023-12-18 | Warnings | M012 |
| Daytime Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79d92d2-d73c-d44f-e053-2995a90a03d9 | 2023-12-15 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL TABLET | Lil' Drug Store Products, Inc. | e5339c39-1d66-b283-e053-2995a90a4317 | 2023-12-15 | Warnings | M012 |
| Father Johns Medicine | DEXTROMETHORPHAN HBR | Humco Holding Group, Inc | a7b0669f-8da1-5a44-e053-2995a90a84d9 | 2023-12-15 | Warnings | M012 |
| Ephedrine Hydrochloride | EPHEDRINE HYDROCHLORIDE | Walgreen Company | bcb81dc1-d854-30c0-e053-2a95a90a9fc7 | 2023-12-14 | Warnings | M012 |
| Allergy, Circle K | DIPHENHYDRAMINE HCL 25MG TABLET | Lil' Drug Store Products, Inc. | d1f370ac-e7f4-baf7-e053-2995a90a1e50 | 2023-12-14 | Warnings | M012 |
| Circle K Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | a6a1e3d9-575c-4adf-beb6-c9719de55c67 | 2023-12-14 | Warnings | M012 |
| Non-Drowsy Sinus Severe, Circle K | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED | Lil' Drug Store products, Inc. | e78c456f-f62e-596d-e053-2995a90a2397 | 2023-12-14 | Warnings | M012 |
| Non-Drowsy Max Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79f1a92-d8ea-e3f9-e053-2a95a90a2d37 | 2023-12-14 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Major Pharmaceuticals | bcc1a001-4176-485d-aaf0-2037ca65c6b8 | 2023-12-14 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Major Pharmaceuticals | edb49b17-06a7-4c25-bc7c-d62c1deac7f1 | 2023-12-13 | Warnings | M012 |
| Family Wellness Oxymetazoline No Drip | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 0c006b1c-8ab2-4b9c-8738-e7001c1bb47d | 2023-12-11 | 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 |